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Lonza AG

Rottenstrasse 6
3930Visp
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Lonza AG

Unternehmen
Lonza ist ein globales Unternehmen, das sich mit seinen Produkten und Service-leistungen an die weltweite Life-Sciences-Industrie richtet. An den Ufern des Flusses Lonza im Wallis mitten in den Schweizer Bergen hat Lonza vor über 100 Jahren als kleines Elektrizitätswerk mit der Herstellung von Chemikalien angefangen. Über 110 Jahre später ist Lonza eine führende Anbieterin von Produkten für die Pharma-, Healthcare-, und Life-Sciences-Industrie.
Wir bieten weltweit 15000 Kunden über 4000 Produkte und Dienstleistungen an. Von 1897 bis heute prägt Innovationsgeist das Unternehmen – dies, indem es seine An-gebote und Dienstleistungen immer wieder den Kundenbedürfnissen angepasst hat. Eine auf Leistungswillen, Ergebnisorientierung und Verlässlichkeit basierende Kultur zieht sich wie ein roter Faden durch unsere Geschichte und wird von allen Kunden geschätzt.
Strategie
Unsere Strategie zielt darauf ab, die Life-Sciences-Industrie mit zwei grundlegenden Technologien anzusprechen: Chemie und Biotechnologie. Unter Anwendung dieser beiden Technologien bieten wir sowohl Produkte als auch Custom-Manufacturing-Dienstleistungen für die Pharma-, Biotech- und Life-Sciences-Industrie an. Indem wir uns auf die Weiterentwicklung unseres Angebotes und auf ein aktives Portfolio-Mana-gement konzentrieren, welches strategische Akquisitionen und Veräusserungen beinhaltet, schaffen wir ein starkes, überdurchschnittliches Wachstum.
2008 kamen beide strategischen Elemente zum Tragen. Um den Kundenfokus zu stärken, hat das Unternehmen 2008 über CHF 400 Millionen in neue Einrichtungen und in den Bau neuer Anlagen investiert. Lonza hat über die Akquisition der technologisch führenden amaxa AG im Juli 2008 auch ihr Angebot im Geschäftsbereich Bioscience erweitert.
Wir sind überzeugt, dass Wissenschaft und Technologie eingesetzt werden sollten, um die Lebensqualität zu verbessern. Diese Vision untermauert unsere Strategie und alle unsere Aktivitäten. Unter Nutzung fortschrittlicher Technologien arbeiten wir mit Begeisterung daran, Life Sciences in neue Möglichkeiten für unsere Kunden umzuwandeln.
Unternehmen
Lonza ist ein globales Unternehmen, das sich mit seinen Produkten und Service-leistungen an die weltweite Life-Sciences-Industrie richtet. An den Ufern des Flusses Lonza im Wallis mitten in den Schweizer Bergen hat Lonza vor über 100 Jahren als kleines Elektrizitätswerk mit der Herstellung von Chemikalien angefangen. Über 110 Jahre später ist Lonza eine führende Anbieterin von Produkten für die Pharma-, Healthcare-, und Life-Sciences-Industrie.
Wir bieten weltweit 15000 Kunden über 4000 Produkte und Dienstleistungen an. Von 1897 bis heute prägt Innovationsgeist das Unternehmen – dies, indem es seine An-gebote und Dienstleistungen immer wieder den Kundenbedürfnissen angepasst hat. Eine auf Leistungswillen, Ergebnisorientierung und Verlässlichkeit basierende Kultur zieht sich wie ein roter Faden durch unsere Geschichte und wird von allen Kunden geschätzt.
Strategie
Unsere Strategie zielt darauf ab, die Life-Sciences-Industrie mit zwei grundlegenden Technologien anzusprechen: Chemie und Biotechnologie. Unter Anwendung dieser beiden Technologien bieten wir sowohl Produkte als auch Custom-Manufacturing-Dienstleistungen für die Pharma-, Biotech- und Life-Sciences-Industrie an. Indem wir uns auf die Weiterentwicklung unseres Angebotes und auf ein aktives Portfolio-Mana-gement konzentrieren, welches strategische Akquisitionen und Veräusserungen beinhaltet, schaffen wir ein starkes, überdurchschnittliches Wachstum.
2008 kamen beide strategischen Elemente zum Tragen. Um den Kundenfokus zu stärken, hat das Unternehmen 2008 über CHF 400 Millionen in neue Einrichtungen und in den Bau neuer Anlagen investiert. Lonza hat über die Akquisition der technologisch führenden amaxa AG im Juli 2008 auch ihr Angebot im Geschäftsbereich Bioscience erweitert.
Wir sind überzeugt, dass Wissenschaft und Technologie eingesetzt werden sollten, um die Lebensqualität zu verbessern. Diese Vision untermauert unsere Strategie und alle unsere Aktivitäten. Unter Nutzung fortschrittlicher Technologien arbeiten wir mit Begeisterung daran, Life Sciences in neue Möglichkeiten für unsere Kunden umzuwandeln.
Merken

10.05.2024

Lonza AG

Director, MES Program Lead (m/f/d)

  • Lonza AG

  • Basel

  • 10.05.2024

  • Festanstellung 100%Management / Kader

Festanstellung 100%

Management / Kader

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The Director, MES Program Lead (m/f/d) is a Senior level position with global responsibility to globalize, standardize and manage all Lonza’s MES (in responsibility of Global Operations): act view E2E view to assure correct 1st implementation and continues operation of MES. In addition push for innovations in area of responsibility, support regional leads in application of these standards. Drive vendor and integrator relationships to optimize outcome and quality of MES implementation. Algin standards with partner organizations, like Operations (Biologics, Small Molecules and CGT), IT, QA, procurement. Key responsibilities: Creation, sharing and continuous improvement of MES usage across the Lonza network incl. procedures, software elements. Sponsor or execute smaller improvement projects and/or work in close collaboration with regional automation leads on overarching growth projects to implement MES. Owns vendor relationship and global software elements (like ERP interface) Drive innovation within MES to achieve improvements to plant operations / throughput / compliance Host network governance board and community of practice (COP) to share and drive alignment in responsibility area Lead, manage and support the development of global automation & MES team members Develop and maintain together with procurement organization strong relationships (master service agreements) with technology suppliers and third party contractors Orchestrate with other Lonza Centers of Excellence to employ best solutions for all projects. Key requirements: Bachelor’s Degree Required – candidate should have BS Engineering, Computer Science or equivalent experience. 10 years of experience with design and operation of API/Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). 8 years of experience with and technically strong in MES (Syncade or similar MES brands), some experience with process controls systems including PCS (DeltaV), SCADA/PLC’s. Preferable in more than one automation vendor. Experience with integrations of MES with Automation systems of level 1/2 (DCS and SCADA/PLC based automation systems) as well ERP, LIMS, IPC devices, eDMS. Preferable experience with PLM solutions. Fluent English – German of advantage Strong communication and teamwork skills, particularly in stressful situations. Ability to influence key/senior stakeholders. Understanding of how to get things done in different cultures. High energy levels with a passion for what you do. Organized and structured with good attention to detail. Strong analytical and problem solving skills Ability to quickly adjust to a dynamic and fast paced environment Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59383Apply Similar JobsR58881 Switzerland, Basel
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Merken

10.05.2024

Lonza AG

Team Manager Data Insights

  • Lonza AG

  • Basel

  • 10.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. As the Team Manager of Data Insights, you will lead a talented team of data engineers, BI analysts, and subject matter experts (SMEs). Your primary responsibility will be to oversee the delivery of data and analytics projects across organization wide, with a strong focus on pharmaceutical manufacturing domain data. Additionally, you will develop and maintain a global strategy for Data Historian (PI) implementation, serving as the Program Manager for its rollout. Key Responsibilities: Lead and manage a team of business data/BI analysts, data SMEs, data services transition managers, and data engineers, providing guidance, mentoring, and support to foster their professional growth. Facilitate requirements engineering processes, ensuring a comprehensive understanding of stakeholder needs and translating them into actionable insights and data solutions to implement data projects. Act as a trusted data partner, advising stakeholders on data-driven decision-making and best practices in utilizing pharmaceutical manufacturing data for business improvement. Develop and maintain a global strategy for Data Historian (PI) implementation, including Data Model based on ISA95 with Asset and Event Framework, and corresponding Master Data management specific to pharmaceutical manufacturing processes. Provide technical expertise and support for the maintenance and implementation of GxP solutions, with a focus on pharmaceutical manufacturing data compliance and best practices. Provide technical guidance and support to the team, ensuring the effective implementation of data pipelines, data modeling, ETL processes, and analytics frameworks. Establish effective communication channels to provide regular updates on project status, key insights, and recommendations to stakeholders and senior management. Occasional domestic and international travel (up to 20%). Perform other duties as assigned, contributing to the overall success of the data insights team and organizational objectives. Key Requirements: Minimum Bachelor’s degree in data science, computer science, information management or other relevant field Proven experience in a leadership role overseeing data teams and delivering data projects, preferably within the pharmaceutical manufacturing domain. Preferred experience in the pharmaceutical manufacturing sector or closely related industries, with a strong understanding of MES, LIMS, QMS, and time series data solutions' data models and structures. Extensive knowledge of Data Historian implementation, particularly with PI systems, ISA95 Data Model, Asset and Event Frameworks, and Master Data management. Strong understanding of GxP compliance requirements and best practices in pharmaceutical manufacturing data management. Proficiency in data analysis tools and techniques, business intelligence platforms, and data visualization tools (Process Analytical Technology tools). Excellent communication, collaboration, and stakeholder management skills. Project management experience, including the ability to effectively plan, execute, and monitor projects to successful completion Fluency in English required, fluency in German preferred Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60166
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Merken

09.05.2024

Lonza AG

Senior-Director (m/f/d) Global Growth Projects

  • Lonza AG

  • Basel

  • 09.05.2024

  • Festanstellung 100%Management / Kader

Festanstellung 100%

Management / Kader

Basel

Switzerland, Basel Switzerland, Visp Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The Senior-Director (m/f/d) Global Growth Projects effectively supports the Global Growth Projects Lead managing key growth projects from the early project definition phase through business case (CAR) approval. Key responsibilities: Provide operational knowledge and support for the early strategic growth investment project pipeline in Biologics from the initiation phase through business case approval Drive proper definition of the project scope and business case through collaboration with cross-functional stakeholders Partner with peers in Global Engineering, Operations, and the Business Unit in delivering the facility design, project milestones, and CAR Provide end-to-end project management support and/or identify end-to-end project leader Contribute to Value Engineering exercise ensuring best value for the money, while preserving all functionalities required to operate the asset effectively Utilize LEAN operational models and facility design, including Automation architecture and functionalities, to drive future operational efficiency Assure incorporation of innovation, lessons learned from other projects and global standards targeting operating costs and enhance operational efficiency Ensure early growth projects follow the proper end to end framework Develop and quantify an aggressive yet realistic ramp up plan in alignment with the business case Approximately 25% travel. Key requirements: Engineering/Science Degree and MBA preferred Strong pharmaceutical manufacturing and engineering knowledge are required Participated and/or led CAPEX projects (100 Mio+ CHF) Ability to handle ambiguity and complexity Ability to adjust to different customer requirements and adapt oneself to different challenges Ability to communicate globally to cross-functional project network Strategic thinker – can think beyond the obvious and apply complex judgment based on technical and operational experience. Business fluent in English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60515Apply Similar JobsR58769 Switzerland, Basel Switzerland, Visp
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Home Office
Merken

09.05.2024

Lonza AG

Associate Director, Drug Product Sales (f/m/d)

  • Lonza AG

  • Basel

  • 09.05.2024

  • Festanstellung 100%Management / Kader

Festanstellung 100%

Management / Kader

Basel

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The primary responsibility of this position is to help drive acquisition of new customers and expand existing customers for the Drug Product Services (DPS) Business Unit (BU). Working collaboratively with Global Sales, Commercial Development and Marketing, the Drug Product Sales Specialist will promote current drug product service capabilities and new offerings and facilitate generation and closing new clinical and commercial business opportunities. Utilizing a strong knowledge of the drug product development and commercial process, the job holder is expected to play a key role in fostering strong customer relationships in conjunction with Global Sales account owners and new customers providing feedback to internal teams so that Lonza can continuously optimize drug product offers and service levels. Key responsibilities: Assigned territory – EMEA Required location: EMEA In close collaboration with Business Development (BD) managers, Account Managers (AM) and Global Account Managers (GAM), manage drafting and implementing Territory Sales Plans for DPS service offering that align with the DPS Business Unit strategy In close collaboration with Business Development managers, Account Managers and Global Account Managers, hunt for new programs for the DPS BU. Demonstrate strategic business awareness of the drug product market and customers in order to differentiate Lonza from the competition Effectively promote current drug product technical capabilities and emerging / new technologies as they become available to help facilitate generation and closing of new business opportunities. Primary means of achieving through e-mail communications, phone conversations, face-to-face meetings, and customer tailored presentations Network and build trust based relationships throughout target accounts from technical personnel to the executive level. Formulate value propositions to generate opportunities to address the customer needs Identify market trends, assesses market potential and develop strategies to grow market share using data from customer base / market and communicating effectively with internal stakeholders. Achieve New Business/New Program wins: Assist the Global Sales team to achieve required Opportunity closure rate Actively lead or support marketing and technical expert (SME) outreach efforts to penetrate target accounts and position Lonza as a market leader in biologics drug product services. Regional marketing activities: Establish and execute regional marketing plan and business activities including Drug Product Business Unit roadshows/events to drive business, regional events and conferences in assigned territory, etc. Maintain up-to-date data in Lonza systems including Salesforce, CPQ, Negotiation Planner, Customer Target Platform (CTP), Omni (Territory Plans), etc. Understand region specific biotech and pharma landscape and CDMO competition. Continually assess Lonza’s position in the CDMO marketplace and adjust territory strategy and plan. Remote/site-based position with up to 50% travel. Perform other duties as assigned. Key requirements: Bachelor’s degree in Life science discipline: Biochemistry, Chemistry, Molecular Biology, Pharmaceutical sciences; MBA, Advanced scientific degree such as Masters or Ph.D. is preferred. Must be business fluent in English Highly experienced within CDMO industry specifically DP: Advanced no of years in commercial or alternatively customer facing technical roles Must have Aseptic filling; fill and finish; liquid vials, lyo vials, Cartridges and PFS or syringes. CDMO background/service industry who provides fill and finish services Must have CRM / SFDC Expertise Must have Negotiation experience Proven track record in delivering year on year business targets for drug product deals Strong technical understanding of drug product development and drug product manufacturing processes Demonstrated track record to secure new customers, exhibiting a strong close rate High level of understanding of the drug product development process from pre-clinical to clinical development and commercialization Effective at working with scientists and other customer stakeholders, up to and including C- Suite leaders, to discuss the value proposition of Lonza’s offerings, whether it be a small or large value deal Understanding of SalesForce.com customer contact management system Strong interpersonal and leadership skills. Creative, adaptable, capable of self-motivation and independence Adept at building strong internal network and navigating a complex matrix organization to optimize influence for ensuring appropriate support levels for territory opportunities Customer facing attitude. The ability to build relationships based on trust and long term commitment. Strong gravitas, particularly in specific technology area of focus Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60019
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Merken

06.05.2024

Lonza AG

Senior Validation Scientist Phys-Chem QC (m/f/d)

  • Lonza AG

  • Basel

  • 06.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Senior Validation Specialist, Physical-Chemical Quality Control Full-time, temporary fixed-term contract position (12 months) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is looking for a Senior Validation Scientist Physical-Chemical Quality Control (m/f/d) for our site in Basel-Stücki for a 12-month fixed-term contract. Key responsibilities: Provide support in the area of cGMP analytical method validation, verification and transfer activities within DPS QC Phys-Chem Analytics: Evaluate and implement analytical methods (e.g. HPLC and CE-SDS purity methods, identity methods, content determination, compendial methods provided by a customer) Independently execute pre-validation, validation or transfer under cGMP (protocol writing, experiment execution or reviewing, and report writing) Oversee assigned tasks, including monitoring timelines, proper execution and reporting Ensure lab clean/maintenance and training status to cGMP standards Support Drug Product analytical infrastructure as assigned Key requirements: Completed apprenticeship (CTA, BTA or equivalent) or academic degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related subject Advanced scientific knowledge of phys-chem analytical techniques Strong working knowledge in relevant analytical techniques in the lab At least 2-3 years experiences in GMP environment Experienced in large molecule analytics (advantageous) Very good planning, reporting, interpretation and documentation skills Good knowledge of written and spoken English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R58835Apply Similar JobsR58990R59654 Switzerland, Basel
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Merken

06.05.2024

Lonza AG

QC Lab Systems Specialist 80-100% (m/f/d)

  • Lonza AG

  • Basel

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Basel

Switzerland, Basel Job Title: QC Lab Systems Specialist 80-100% (m/f/d) Location: Basel, Switzerland Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as QC Lab Systems Specialist. Key responsibilities Qualification/validation of analytical equipment in Phys. Chem. and Bioanalytics QC laboratories Writing key qualification documents including: URS, Risk Assessment, OQ/PQ Plans and Reports Supervise testing (IQ, OQ, PQ) Review and approve qualification/validation related reports as required following cGxP Maintain equipment in Phys. Chem. and Bioanalytics QC laboratories in alignment with relevant SOPs Collaborate with cross functional teams and stakeholders Act as subject matter expert for laboratory system qualification within audits and inspections Act as administrator for dedicated lab systems as per defined SOPs and instructions Key requirements Degree in e.g. Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering or on the job training as an Analytical Lab Technician Extensive experience in analytical equipment qualification Excellent understanding of relevant regulatory requirements Knowledge of quality management systems (e.g. TrackWise) is a plus Good communication skills Ability to work in a highly dynamic environment Good inter-personal skills Good knowledge of English (written and spoken, German is a plus) Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R58660Apply Switzerland, Basel
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Merken

06.05.2024

Lonza AG

QA Expert Compliance (m/f/d)

  • Lonza AG

  • Basel

  • 06.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Stein and Visp Switzerland we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as QA Expert Compliance. Key responsibilities: Drafts, negotiates and finalizes Quality Agreements with Suppliers and Service Providers Ensures the proper qualification of material/service suppliers by supervising adherence to global QMS requirements Interacts with the Global Supplier Qualification team by acting as local Point of Contact for the line units of Drug Product Services in both Basel and Stein Supports establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for QC in Basel and manufacturing plants in Stein Prepares, reviews and approves GMP documents such as SOPs, Work Instructions for assigned topics Supports customer audits and health authority inspections as required Acts as system coordinator at local level for systems like DMS, Trackwise, SAP Key requirements: Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field Solid working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in production and/or analytics. Experience with supplier qualification is a plus. Very good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems Sound knowledge in compliance systems for document lifecycle management, training management and workflow tools (e.g. TrackWise) Ability to handle complex situations successfully, and to define tasks self-reliantly after discussion with line manager Highly organized work style to ensure multiple assigned projects can be handled in parallel Very good knowledge of written and spoken English; German is a plus Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59609Apply Switzerland, Basel
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Home Office
Merken

06.05.2024

Lonza AG

Internal Auditor / Audit Manager (f/d/m)

  • Lonza AG

  • Basel

  • 06.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For our small, but impactful internal audit team, we are looking for a highly motivated and talented auditor or audit manager (depending on level of experience). Your task will be to support or lead/execute internal audit assignments within the Lonza Group, while getting to know the business and developing your expertise for a line management career. Role / Main Responsibilities: As an auditor, plan, execute and finalize the audit of assigned areas; develop into the audit manager position within approximately 12 months. As a manager, lead and conduct internal audit assignments, including training, supervision and guidance of team member(s) and/or outsourced experts assigned to individual engagements, while also covering your own audit area(s). Execute audit and advisory activities in any area mandated (e.g., supply chain management, sales, production, finance & accounting, major investments as well as strategic projects). Evaluate and strengthen the effectiveness of Lonza’s governance, risks management and control processes; identify risks and weaknesses, as a basis for recommendations which add value and help management to improve the organization’s operations and accomplish their objectives. Use available tools and constantly develop/train your know-how regarding applications and IT infrastructure to optimize audit preparations and execution, e.g. by applying advanced data analytics, assessing access design or key configurations of main applications; support or drive initiatives in this area aiming at ongoing improvements and increasing efficiencies regarding audit programs and processes. As part of assignments or related to consulting requests, participate in discussions with key stakeholders and management, e.g., global process owners or site leadership team, to raise awareness for new risks and support corresponding risk management as well as implementation of best practices and standardization requirements. Follow-up on audit recommendations’ implementation and support the reporting on open and overdue issues to top management. Lead initiatives and/or contribute to other internal activities and projects constantly optimizing the Internal Audit function. Minimum Required Qualifications / Skills: BA/BSc, preferably in finance / accounting, degree in chemistry or similar also welcome 3+ years of internal / external audit experience (preferably experience from manufacturing industries) Excellent understanding of standard business processes like S2P, OTC, R2R, mandatory controls in these areas and how to assess these, especially in SAP environment (ideally including S4H experience) Solid know-how / regular use of SAP with a good level of understanding of SAP tables / reports; experience with SAP configuration implementation / audits would be advantageous At least basic knowledge of IT fundamentals; competence to execute audits of operational and finance activities which are run with special applications (e.g., Salesforce.com or CRM) Very experienced in executing assignments in compliance with international standards of auditing; CIA preferred (otherwise completion after hire mandatory) Good analytical skills, risk focused, target and deadline oriented, result driven and solution developer, motivated self-starter Knowledge of ETL concepts and familiarity with SQL, Python programming and/or Power BI dashboards a plus Team player and very good communicator with leadership skills and potential to develop career further within the Lonza Group after 3-4 years in internal auditing Fluent in English (oral and in writing) Travel requirements approximately 20% Location: Basel Headquarters (relocation necessary; home office limited to max. 2 days per week) Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60011Apply Switzerland, Basel
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Merken

06.05.2024

Lonza AG

Global OT Systems Quality Manager

  • Lonza AG

  • Basel

  • 06.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Switzerland, Visp Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. You will work in a small team and a global environment to ensure that our world-wide projects are carried out with a high quality. The various amount of projects are a very good opportunity to grow personally and professional in an fast developing environment. Key responsibilities: Establishing and maintaining the global MES systems quality and validation policies, risk-based standards, and procedures in line with internal and external regulations Coordinating the validation of MES computer systems software, related interfaces and infrastructure Quality oversight of global MES standard systems, interfaces and infrastructure, including but not limited to evaluation of changes and deviations, in cooperation with Centers of Excellence, supporting periodic reviews, and internal and external audits Consulting and advising Global MES computer systems projects on the correct application of internal and external regulations Key requirements: Bachelor of Science in IT, OT, Informatics, Automation, engineering, process engineering, electronics engineering, Data Science or a related field Broad experience in Computerized System Validation (CSV) and infrastructure qualification in the pharmaceutical environment Experience working in Computerized System Compliance and Data Integrity Experience working together with stakeholders on different management levels Experience working in MES implementation projects would be a real advantage Fluent English language skills are required, German or French language skills would be an advantage Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59821Apply Switzerland, Basel Switzerland, Visp
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05.05.2024

Lonza AG

Senior Manager, Digital Marketing (f/d/m)

  • Lonza AG

  • Basel

  • 05.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel United Kingdom, Slough Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work Lonza wants to be part of. As a Senior Digital Marketing Manager , you will be responsible for the end-to-end digital marketing strategy for one of Lonza’s CDMO Divisions. Your responsibilities include co-creating and translating marketing strategies into effective digital campaigns, managing integrated digital messaging, controlling budget, and driving brand awareness. The role is also responsible for developing and evolving the social media and digital advertising channels across all of Lonza’s CDMO Divisions, continuously improving practices to adapt to market changes. Key responsibilities: Co-develop, implement, manage, and measure a communications strategy across all digital channels within one of Lonza’s CDMO Divisions. This includes driving awareness, engagement, lead creation, and development/nurturing. Develop and execute short- and long-term digital campaigns aligned with Division marketing plans, track spending, measure effectiveness, and provide recommendations for future planning. Collaborate with Division marketing teams and sales to promote integrated offerings. Target potential customers through segmentation and personalization tactics. Choose suitable digital strategies and channels to support the marketing plan for one of Lonza’s CDMO division’s, including website inquiries, on-demand webinars, inbound inquiries, dedicated email channels, and other relevant digital channels. Develop and execute nurturing strategies with relevant content. Collaborate on digital communications activities with strategic marketing and sales, measure impact, and provide recommendations for adjustments Lead cross-CDMO division social media and digital advertising strategies aligned with awareness building and customer acquisition goals. Evolve organic content guidelines, optimize paid social strategy, and measure effectiveness of targeted full-spectrum digital advertising. Collaborate with stakeholders to manage content and drive continuous process improvement using analytics and adaptive strategies. Collaborate closely with the reporting and analytics function to optimize digital initiatives and tactics. Track and measure the effectiveness of social programs and digital advertising and refine approach based on data and stakeholder consultation. Provide ongoing reports on impact and funnel metrics, manage dashboard inputs, and propose ROI-improving recommendations. Guide A/B creative tests for digital assets in collaboration with marketing teams within the Division.. Analyze Lonza’s social media and digital advertising strategies, identifying trends, technical advancements, and methodical improvements. Propose forward-thinking solutions to enhance our digital presence, collaborating with the digital marketing team and ensuring alignment with corporate communications and product division strategies. Key requirements: BA Marketing, digital communications or similar business diploma In-depth knowledge and experience of digital marketing techniques: social media marketing, SEO, PPC campaigns, mobile etc. as well as SEM, Google Analytics (Tag manager, Search Console etc.), marketing automation and CRM software Several years’ experience in a digital marketing role in a b2b business, developing and executing multi-channel campaigns with a strong focus on digital marketing techniques and strategy Several years’ experience of implementing, managing and optimizing social media and digital advertising strategies and platforms Demonstrated success in a multi-channel campaign management role and experienced in developing and executing digital communications strategies for a business Experience working with marketing analytics, reporting best practices, 3rd party technologies, agencies and requirements gathering A strong understanding of how a CMS system works and the interaction with marketing platforms Intermediate HTML and CSS knowledge for building emails Strong understanding of how online customer journeys interact with the sales process and an understanding of how leads and opportunities are optimally tracked and measured through a sales pipeline Strong project management skills and the ability to prioritize and meet deadlines when working on multiple projects under pressure Pharma/life sciences industry experience or a related area a plus Every day, Lonza’s products and services have a positive impact on millions of people. For Lonza, this is not only a great privilege, but also a great responsibility. How they achieve their business results is just as important as the achievements themselves. At Lonza, they respect and protect their people and their environment. Any success Lonza achieves is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, Lonza offers the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60012Apply Switzerland, Basel United Kingdom, Slough
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04.05.2024

Lonza AG

Technical Proposal Manager (f/m/d)

  • Lonza AG

  • Basel

  • 04.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. This person will be responsible for the evaluation and translation of customer needs from RFI/RFP into project scope, timelines, cost and pricing by coordinating and working with multiple technical, operational and commercial groups. Key responsibilities: Overall accountability for creation of “fit for purpose” proposals that: understand and meet customers’ needs, are supported by and aligned with operations to maximize Lonza’s chance of winning projects and to support Sales in securing new business. Responsible for the evaluation and translation of customer needs from RFI/RFP into project scope, timelines, costs and pricing by coordinating and working with multiple technical, operational and commercial groups Defines scope based on information from subject matter experts and evaluation team, agree tailored offering and determine cost for proposed scope. Drafts well-structured proposals reflecting a tailored offering matching client’s needs and provide proposal for review to commercial development. Presents scope, operational model and costing to commercial development for sign off and price setting. Connects with other sites and technologies as appropriate to ensure the whole Customer Product Lifecycle joins up into one plan. Schedules internal meetings to align team and assure collection of critical information needed for delivery of a competitive proposal. Aims to meet timelines for delivery of proposals. Key requirements: Masters in the field of life sciences or related discipline (Biotechnology, Biochemical Engineering, Biology or Biochemistry or related field preferred) Business fluent in English Demonstrated ability to manage multiple, scientific projects and make sound scientific and regulatory interpretations and judgments. Strong project coordination and management skills. Customer facing experience. Experience working in a Contract Manufacturing Organization highly preferred Solid understanding of Drug Product development with ability to understand other related technical disciplines Experience in working with a multi-national team. Enjoys complex fast pace and fast moving environment Strong interpersonal, collaborative and communication skills appropriate to a matrix environment. Ability to develop operational models in collaboration with subject matter experts. Ability to identify creative commercial, workable solutions. Proven persuasive communication skills in a scientific and technical environment. Ability to manage multiple priorities in a fast paced, pressured environment. Self-driven, strong team player, innovative and entrepreneurial spirit, strong communicator, customer focused, can-do-attitude, good IT skills Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60053Apply Switzerland, Basel
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02.05.2024

Lonza AG

Scientist Commercial QC Bio Analytics 80-100% (all genders)

  • Lonza AG

  • Basel

  • 02.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Basel

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For our site in Basel, we are looking for Scientist Commercial QC Bio Analytics. Key responsibilities: Analyses for DP (DS) batch release, stability and related samples under cGMP within DPS Commercial QC using biochemical assays such as cell based assays, ELISA, SPR/Biacore Documentation according to GDP standards and following applicable EHS regulations. Review analytical raw data for assays Act as method trainer and instrument responsible person in area of expertise Support transfer and validation activities and investigations Key requirements : Completed apprenticeship (Laborant EFZ, CTA, BTA or equivalent) or B.Sc. in analytical chemistry, biochemistry, Pharmaceutical Sciences or related subject Basic knowledge of bioanalytical techniques (e.g. cell based assays, ELISA, SPR/Biacore) Strong working knowledge in relevant analytical techniques in the lab At least 2 years experiences in GMP environment, preferably commercial Experienced in large molecule analytics (advantageous) Thorough and accurate scientific attitude, strong analytical, reporting, and documentation skills Good knowledge of written and spoken English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60173
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02.05.2024

Lonza AG

Project Lead Commercial QC 80-100% (all genders)

  • Lonza AG

  • Basel

  • 02.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Basel

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For our site in Basel, we are looking for Project Lead Commercial QC: Key responsibilities: Represent Lonza in internal and customer meetings as project champion Enable release and stability testing of late phase (PPQ and Commercial) Drug Product (MABs, ADC, mRNA) within Lonza QC by: Project coordination (timelines and deliverables are visible and maintained in planning tools), in collaboration with Program Manager Implementing the testing strategy (evaluation of method performance, suitability, control strategy, specifications setting) Acting as regulatory liaison for QC in collaboration with the Lonza regulatory expert team Leading discussions with customers and interface with SMEs Ensuring the de.g. Bio-Chemical testing, Physico-Chemical testing, Forensic Chemistry, Microbiology, incoming goods control, manufacturing, MSAT (Manufacturing, Science & Technologies), QA, Regulatory) Supporting draft of proposals and manufacturing contracts (SoWs) Maintaining up-to-date knowledge of assigned projects (molecules, formulation, product presentation) Demonstrating knowledge of analytical testing by e.g. compendial and generic methods, HPLC and (i)CE purity methods, content determination, Bio-chemical methods (ELISA, SPR, Cell based potency / binding / activity assays), qPCR, MS, dimension testing. Adhere to cGMP regulations QC Project SME for audits and inspections Key requirements: Degree in Life science or management (Bachelor, Master, Ph.D., MBA or similar) Scientific and GMP experience, commercial and financial acumen Strong analytical and problem-solving skills Substantial experience in QC, project management, QA or similar Results oriented and able to prioritize workload to meet timelines Knowledge of pharmaceutical regulatory landscape (e.g. ICH guidelines, PIC/s, US FDA, PMDA, EMA) Excellent communication skills, command of English, academic writing Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60171
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02.05.2024

Lonza AG

Lead Scientist Commercial QC 80-100% (all genders)

  • Lonza AG

  • Basel

  • 02.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Basel

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For our site in Basel, we are looking for Lead Scientist Commercial QC . Key responsibilities: Review analytical testing documentation according to SOPs for clinical and commercial samples. Support implementation, validation, transfer analyses to perform release and stability testing under GMP, following applicable SOP’s and all current documentation practices. Contribute to the establishment of DPS Commercial QC infrastructure and services for e.g. parenteral clinical and commercial Drug Substance and Drug Products under GMP. Support QC release decision, including LIMS Support Empower 3.x Support to maintain the qualified state of analytical instruments for DPS QC in close alignment with current best practices and regulations Raise and progress laboratory investigations and quality events (e.g. OOS, SST, deviations, CAPA, tasks) Contribute to the evaluation and establishment of analytical methods and technologies as required Ensure safety and health protection by following lab and safety instructions and all cGMP regulations. Key requirements: Degree in life sciences or management (Bachelor, Master, Ph.D., MBA or similar) Scientific and GMP experience, commercial and financial acumen Strong analytical and problem-solving skills Substantial experience in QC, project management, QA or similar Results oriented and able to prioritize workload to meet timelines Knowledge of pharmaceutical regulatory landscape (e.g. ICH guidelines, PIC/s, US FDA, PMDA, EMA) Excellent communication skills, command of English, academic writing Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60168
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01.05.2024

Lonza AG

Scientist QC Commercial Physico Chemistry 80-100% (all genders)

  • Lonza AG

  • Basel

  • 01.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For our site in Basel, we are looking for Scientist QC Commercial Physico Chemistry: Key responsibilities : Implement, validate, transfer analyses to perform release and stability testing under cGMP, following applicable SOP’s and all current documentation practices. Focus area: compendial testing, pH measurement, osmolality, purity testing HPLC, iCIEF, CE-SDS Perform sample analysis and review according to SOPs for clinical and commercial samples. Contribute to the establishment of DPS Commercial QC infrastructure and services for e.g. parenteral clinical and commercial Drug Substance and Drug Products under GMP. Maintain the qualified state of assigned instruments for DPS QC in close alignment with current best practices and regulations Contribute to the evaluation and establishment of analytical methods and technologies as required Contribute to timely execution of assigned development projects, including monitoring timelines, proper execution and reporting. Draft validation plans and reports. Ensure safety and health protection by following lab and safety instructions and all cGMP regulations. Key requirements : Completed apprenticeship (Laborant EFZ, CTA, BTA or equivalent) or B.Sc. in analytical chemistry, biochemistry, Pharmaceutical Sciences or related subject Basic knowledge of physico chemical analytical techniques (e.g. pH measurement, osmolality, HPLC, iCIEF, CE-SDS) Strong working knowledge in relevant analytical techniques in the lab At least 2 years experiences in GMP environment, preferably commercial Experienced in large molecule analytics (advantageous) Thorough and accurate scientific attitude, strong analytical, reporting, and documentation skills Good knowledge of written and spoken English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60176Apply Similar JobsR60173 Switzerland, Basel
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01.05.2024

Lonza AG

Quality Assurance ,Warehouse Compliance Manager

  • Lonza AG

  • Basel

  • 01.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Quality Assurance Manager (Warehouse Compliance Manager) Location: Basle/Switzerland Fixed Term Contract – End Date December 2025 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Role Purpose: Warehouse Quality compliance Manager to ensure quality oversight of Lonza Sales over respective warehouses. Key responsibilities: SOP Development and Implementation: Collaborate with cross-functional teams to set up Standard Operating Procedures (SOPs) for warehouse quality oversight. Create an SOP specifically addressing quality checks, inspections, and inventory accuracy. Ensure that all warehouse staff are trained on SOP compliance Ensure that products-related GMP activities that are delegated or contracted to other Lonza GROUP sites or third party contract sites by the RP are controlled through agreements and where appropriate audits. Ensure compliance to the conditions of the Wholesale Distribution Authorization and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and Swiss Medic’s guidelines Ensure that products-related GDP activities that are delegated or contracted to other Lonza Sales AG sites or third party contract sites by the RP are controlled through agreements and where appropriate audits. Ensuring that a quality management system is implemented and maintained Ensure contribution to the implementation of a quality risk management system Ensure Product Review evaluation is performed in the area of responsibility Ensure participation and contribution in the Management Review in the area of responsibility Ensure inspection readiness for Lonza Sales AG. Key requirements: Master's degree in chemistry, biotechnology, life science or related field. 5 years experience within the pharma industry Knowledge of GDP requirements and regulations would be preferred GDP or other relevant certifications would be a plus Familiarity with warehouse safety regulations and best practices Strong organizational and problem-solving abilities. Strong attention to quality Excellent verbal, written and interpersonal communications skills in English (German is a plus) Ability to align cross functional stakeholders to ensure GDP compliance Must interpret and maintain proficiency in regulations, standards, guidelines and trends in GDP Responds independently to most major issues but escalates all critical issues to supervisor Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. #LI-SG1 Reference: R60032Apply Similar JobsR59692R60027R60030R60033 Switzerland, Basel
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01.05.2024

Lonza AG

Quality Assurance ,Supply Chain Compliance Manager

  • Lonza AG

  • Basel

  • 01.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Quality Assurance Manager (Supply Chain Compliance Manager) Location: Basle/Switzerland Fixed Term Contract – End Date December 2025 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Role Purpose: Assist the implementation of integrated offering for Lonza Sales AG. Key responsibilities: Responsible for ensuring compliance with: Federal Act on Medicinal Products and Medical Devices (HMG SR 812.21) Medicinal Products Licensing Ordinance (AMBV SR 812.212.1) Ordinance on Medicinal Products (VAM SR 812.212.21) Good Distribution Practice of Medicinal Products for Human Use (2013/C 343(01)) Falsified Medicines Directive (2011/62/EU) Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland (Swissmedic I-SMI.TI.18) Good Manufacturing Practice (Eudralex vol. 4) in line with oversight of licensed activities associated with contract manufacturing activities, as required per Swissmedic Oversee shipment validation processes to maintain product quality and safety Oversee the qualification of service providers Create / implement the temperature monitoring and transportation related incidents SOP. Assessment of transportation carrier routes and modes. Provide expertise in Regulatory Compliance for the products traded by Lonza Sales AG Ensure that products-related GMP activities that are delegated or contracted to other Lonza Sales AG sites or third party contract sites by the RP are controlled through agreements and where appropriate audits. Key requirements: In depth knowledge of Good Distribution Practice requirements and regulations, experience in warehouse management is an asset 5+ years experience within pharma industry, preferably in a QA or GMP focused role GDP certificates or other relevant certifications is a plus Understanding of the cGMP regulations, especially GDP Strong organizational and problem-solving abilities. Ability to work autonomously with and to develop procedures if required Ability to oversee project execution to identify non-compliance from quality standards Excellent verbal, written and interpersonal communications skills in English (German is a plus) Ability to work in partnerships as an active member of a team and or/cross functional working groups Requires independent decision making regarding quality and compliance. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. #LI-SG1 Reference: R60030Apply Similar JobsR59692R60027R60032R60033 Switzerland, Basel
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01.05.2024

Lonza AG

Quality Assurance, QMS Manager

  • Lonza AG

  • Basel

  • 01.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Quality Assurance Manager (QMS Specialist) Location: Basle/Switzerland Fixed Term Contract – End Date December 2025 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Role Purpose: Develop and maintain the QMS of Lonza Sales AG Key responsibilities: Collaborate with cross-functional teams to design, implement, and continuously improve the QMS. Develop and maintain SOPs, work instructions, and quality manuals related to trade, import, and wholesale processes. Conduct internal audits and assessments to identify areas for improvement. Ensure compliance with Swiss and international regulations (e.g., Swissmedic, EU GMP). Provide training to staff on QMS procedures and quality-related topics. Investigate deviations, CAPAs, and non-conformities, implementing corrective actions as needed. Monitor supplier quality and perform risk assessments. Participate in regulatory inspections and support external audits. Ensuring that a quality management system is implemented and maintained Ensure contribution to the implementation of a quality risk management system Ensure Product Review evaluation is performed in the area of responsibility Ensure participation and contribution in the Management Review in the area of responsibility Focusing on the management of authorized activities and the accuracy of and quality of records Ensure inspection readiness for Lonza Sales AG. Supporting the Responsible Person (FvP) of Lonza Sales AG during regulatory inspections. Key requirements: Master's degree in chemistry, biotechnology, life science or related field. 5 years experience within the pharma industry In depth knowledge of GDP practice requirements and regulations Strong knowledge of QMS Principles, ICH Guidelines GDP Certificates or other relevant certifications are a plus Strong attention to quality Excellent verbal, written and interpersonal communications skills in English (German or French is a plus) Requires independent decision making regarding quality and compliance Professional attitude to sustain excellent working relationships with other sites and regulators Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. #LI-SG1 Reference: R60027Apply Similar JobsR59692R60030R60032R60033 Switzerland, Basel
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01.05.2024

Lonza AG

Quality Assurance Manager

  • Lonza AG

  • Basel

  • 01.05.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Quality Assurance Manager Location: Basle/Switzerland Fixed Term Contract – End Date December 2025 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Role Purpose: The Lonza Sales AG Quality Assurance manager exercises the quality oversight of all products from Lonza’s sites in China, USA, Spain and the UK that are traded via Lonza Sales AG and has regular contact with those sites. Key responsibilities: Establishing and maintain contact with the relevant stakeholders at Lonza’s manufacturing sites worldwide. Oversight and documentation of Lonza Sales AG’s trading activities including confirmation of compliance with FAMI QS and GDP (Good Distribution Practices) requirements. Establishing monthly reports on traded goods as well as Annual Product Reviews (APQRs) and Management Review reports. Following up with the different sites any corrective actions needed. Prepare the monthly Quality Councils for Lonza Sales AG. In collaboration with Lonza AG’s experts, develop and implement IT solutions to allow better oversight of site specific documentation. Together with the Responsible Person (FvP) of Lonza Sales AG further develop the Quality Management Systems (QMS). Maintaining a compliant and efficient QMS. Ensure inspection readiness for Lonza Sales AG. Supporting the Responsible Person (FvP) of Lonza Sales AG during regulatory inspections Key requirements: Ph.D. or Master’s degree in Chemistry, biotechnology, life science or related field 3+ years experience within pharma industry, preferably in a QA or GMP focused role Understanding of the cGMP regulations, especially GDP Competent level of general IT skill is required Auditing experience is an asset Strong organizational and problem-solving abilities. Ability to work autonomously with and to develop procedures if required Ability to oversee project execution to identify non-compliance from quality standards Excellent verbal, written and interpersonal communications skills in English (German is a plus) Ability to work in partnerships as an active member of a team and or/cross functional working groups Requires independent decision making regarding quality and compliance. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. #LI-SG1 Reference: R60033Apply Similar JobsR59692R60027R60030R60032 Switzerland, Basel
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29.04.2024

Lonza AG

Senior Validation Scientist PhysChem QC

  • Lonza AG

  • Basel

  • 29.04.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Senior Validation Specialist, Physical-Chemical Quality Control (m/f/d) Full-time, permanent position. Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is looking for a Senior Validation Scientist Physical-Chemical Quality Control (m/f/d) for our site in Basel-Stücki. Key responsibilities: Provide support in the area of cGMP analytical method validation, verification and transfer activities within DPS QC Phys-Chem Analytics: Evaluate and implement analytical methods (e.g. HPLC and CE-SDS purity methods, identity methods, content determination, compendial methods provided by a customer) Independently execute pre-validation, validation or transfer under cGMP (protocol writing, experiment execution or reviewing, and report writing) Oversee assigned tasks, including monitoring timelines, proper execution and reporting Ensure lab clean/maintenance and training status to cGMP standards Support Drug Product analytical infrastructure as assigned Key requirements: Completed apprenticeship (CTA, BTA or equivalent) or academic degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related subject Advanced scientific knowledge of phys-chem analytical techniques Strong working knowledge in relevant analytical techniques in the lab At least 2-3 years experiences in GMP environment Experienced in large molecule analytics (advantageous) Very good planning, reporting, interpretation and documentation skills Good knowledge of written and spoken English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59369Apply Switzerland, Basel
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29.04.2024

Lonza AG

Innovation Intern, Licensing

  • Lonza AG

  • Basel

  • 29.04.2024

  • Festanstellung 100%

Festanstellung 100%

Basel

Switzerland, Basel Innovation Intern, Licensing Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. In our Licensing Business Unit, we are committed to fostering innovative solutions and delivering exceptional service to our clients worldwide. We are committed to innovation and excellence in the healthcare sector, driving forward new ventures and partnerships. We are seeking a highly motivated Innovation Intern to join our team in Basel, Switzerland to support the management of Lonza’s internal and external innovation activities. The Innovation Intern will play a pivotal role in establishing processes, managing critical documentation, and supporting project initiatives. This internship is ideal for an individual with a keen interest in the interface between business and technology. The successful candidate will gain invaluable hands-on experience by working closely with our Innovation and Venture Fund functions in the Licensing Business Unit, contributing to deal flow management, diligence efforts, and business case support for engagement with new technologies. Key responsibilities: Assist in managing external deal opportunities and support diligence efforts in a detailed, logical, and progressive manner during deal evaluation. Collaborate with the Innovation teams to gather and analyze data for business cases and initiatives. Prepare and refine presentation decks and documents for internal and external meetings. Conduct research on industry trends, competitive landscapes, and potential partners. Support administrative tasks related to innovation and venture initiatives, including planning and monitoring of project timelines and deliverables. Participate in continuous improvement initiatives, suggesting ways to optimize processes and customer experiences. Perform other duties as assigned Key requirements: Currently pursuing or have recently completed a degree in Business Administration, Data Science, Project Management, or a related field. Demonstrated skills in data analysis and document management. Excellent communication skills, both written and verbal. Strong organizational skills and attention to detail. Proactive mindset with the ability to anticipate project needs and take initiative Soft Skills: Proactiveness: Ability to anticipate issues and act on them before they become problems. Attention to Detail: Ensures accuracy and completeness in all tasks and communications. Collaborative mindset: Ability to work in a collaborative matrix environment. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60297Apply Switzerland, Basel
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28.04.2024

Lonza AG

Global Head Asset Management and Environmental Engineering (m/f/d)

  • Lonza AG

  • Basel

  • 28.04.2024

  • Festanstellung 100%FührungspositionManagement / Kader

Festanstellung 100%

FührungspositionManagement / Kader

Basel

Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The Head of Asset Management and Environmental defines and implements Lonza’s Asset Management Program (LAMP) including related digitalization & automation activities as well as ESG concepts in collaboration with global and site stakeholders based on evaluation of Lonza’s engineering and maintenance processes, system controls, effectiveness, sustainability, etc. and benchmarking to industry-standards/best-practices. She/he is accountable for the global evaluation, execution and continuous improvement of compliant, effective, efficient and state of the art E&M standards at Lonza. The purpose of this role is to achieve a high reliability of engineering and maintenance disciplines across Lonza’s network at competitive cost. The Head of Asset Management and Environmental defines and rolls out the overall environmental and sustainability program from engineering across the different streams such as green technologies in growth projects, carbon foot print optimization within operations, regional workshops to identify potential CO, waste and water reductions, align all business units and stakeholders on the site sustainability road map, including the governance, reporting and the CapEx master plant to achieve the sustainability commitment with customers and within the company policy. Key responsibilities: Further develop Lonza’s asset management program, define and lead related work streams which address harmonization, efficiency, reliability, digitalization and sustainable asset life cycle management Develop work streams which address topics like: processes and organization of E&M, planning and scheduling, workspace and workflows, spare part management, maintenance strategy, KPI definition and control, OEE measurements, Reliability and Maintenance Effectiveness Reviews, Costing, Sustainable Asset Management and IT tools Implement best practices in Engineering or Maintenance in a multi-site environment within a matrix organization Ensure a culture of mutual accountability and full collaboration with customers and diverse Lonza sites as well as departments for effective implementation and sustainable endorsement of standards Contribute in a risk based manner to production unit refurbishment, asset recapitalization and new constructions to build-in best practices in E&M; Define global and local road maps, KPIs and governance for environmental. Establish the green technology catalog for growth project and recapitalization as new standard. Manage and oversee environmental projects execution to achieve the yearly targets. Stablish long term environmental policies and standards to minimize the impact of operations across waste, water, electricity, steam among others consumptions. Key requirements: 10+ years’ experience in Engineering/ Maintenance in a highly controlled environment with high standards in technology such as the biopharmaceutical industry, green technology, among others. High level of program and/or project management skills and familiar with Operational Excellence tools Very high project management skills specifically on project planning and execution. High communication and presentation skills to stakeholders, customers and SteerCos. Highly customer-focused, with demonstrable stakeholder management experience and passionate about delivering high quality innovative solutions and services that meet business needs, which are readily scalable A proven track record of running high performing environments, including virtual teams. Innovative, responsible, and reliable with a highly developed strategic mindset Analytical and critical thinking skills. Ability to formulate hypothesis and translate into actionable plans Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60068Apply Switzerland, Basel
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10.05.2024

Lonza AG

MES Specialist DPS Growth Project 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 10.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as MES Specialist DPS Growth Project 80 – 100% supporting a new sterile Drug product facility. Key responsibilities: Work closely with MES manager, system users and process owners to develop and revise MES recipes in a timely manner Configure production recipes using a library of objects and manage MES master data like Products, Locations, Equipment, Materials Assist in fulfilling requirements of quality records such as process change controls, CAPA and deviations Draft and execute test script for the validation of recipes (IQ, OQ, PQ) Establishment and further development of interfaces to other systems such as ERP, LIMS and automation and work closely with this departments Development of concepts for an optimal data flow with the interfaces, taking into account all use cases Definition of requirements for the MES system for its further development Support production via the Helpdesk, assisting with production issues Key requirements: Academical degree minimum Bachelor degree preferred in a technical field and/or engineering Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects) Familiarity with GMP requirements, quality procedures and SOP execution Previous exposure to any of the commercial MES systems (Rockwell PharmaSuite, Werum Pas-X, POMS, Emerson Syncade). Good communication skills and interaction with a variety of interface within the organization and the shop floor Strong team orientation Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R56288Apply Switzerland, Stein
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10.05.2024

Lonza AG

Training Specialist DPS Growth Project 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 10.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The Training Specialist is responsible for the design, implementation, and evaluation of training programs across various departments for employees at Lonza's sterile fill and finish Growth Project. This role focuses on enhancing employee skills, performance, productivity, and quality of work. Key Responsibilities: Conduct organizational assessments to identify training needs and gaps, collaborating with department managers. Develop training curricula, including course outlines, instructional materials, and assessment tools. Facilitate training sessions using a variety of instructional techniques, such as classroom training, virtual training, on-the-job coaching, and e-learning. Monitor and evaluate the effectiveness of training programs, utilizing relevant evaluation tools like surveys and assessments. Maintain comprehensive records of training activities, materials, and participant progress. Ensure all training activities and materials meet compliance standards and regulations. Manage training resources, including venues, equipment, and materials, ensuring optimal utilization. Leverage Learning Management Systems (LMS) to schedule, track, and report on training activities. Keep abreast of the latest trends and technologies in training and development to ensure programs remain current. Regularly communicate with management and other key stakeholders on training progress, challenges, and outcomes. Key requirements: Completed apprenticeship in relevant field and or university degree. GMP Knowledge. Some experience in training and or aseptic environments. Strong organizational and project management skills. Familiarity with Learning Management Systems (LMS) e.g. Cornerstone on Demand. Excellent verbal and written communication skills. Proficiency in Microsoft Office Suite. Ability to work independently and as part of a team. Fluency in German and English. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60382Apply Switzerland, Stein
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09.05.2024

Lonza AG

HVAC & Utilities Engineer DPS Growth Project 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 09.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as HVAC & Utilities Engineer DPS Growth Project 80 – 100% supporting a new sterile Drug product facility. Key responsibilities: Participate in FATs, construction walkdowns, C&Q to allow a smooth hand-over of Black-, Clean-Utilities & HVAC After Handover ensure the operation and the correct execution of all maintenance activities of Black-, Clean-Utilities & HVAC equipment in compliance with Safety and cGMP requirements Carries out all activities to maintain complete and up-to-date system documentation Support risk analysis and establish Sops and work instructions for the new facility and equipment in the area of responsibility Maintaining qualification status (regarding safety and cGMP) of the assigned areas Consistent recording and maintaining data of functional locations, equipment and spare parts, spare part lists, instruction manuals and SOPs, etc. Maintaining history and records in SAP and actual status of plant PIDs Ensures deviation and change management across its entire area of responsibility. Represents facility during inspections and audits as SME for area of responsibility Key requirements: Degree in engineering or comparable degree in economics with a technical focus and a strong technical understanding (HF, FH, Dipl. Ing. / M. Sc. / B. Sc.) Significant experience in equipment maintenance, ideally in operation of a pharmaceutical company Good knowledge of SAP-PM and MS Office Knowledge of GMP compliance requirements preferred Strong analytical skills with the ability to define metrics (KPI’s) and identify issues Fluency in German and English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60327
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06.05.2024

Lonza AG

(Senior) QA Expert Manufacturing Release 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Senior QA Expert Manufacturing Release 80-100% Location – Stein, Switzerland Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The primary purpose of the role is to ensure a Right Time in Inspection Readiness for a Big CAPEX project (encompassing a Fill Finish Facility, Laboratories, Warehousing, Shipment and Offices). The role will manage QA operational activities to support departmental projects and objectives according to agreed timelines and standards and ensure compliance with GMP is maintained in Sterile Production Plant Stein. Then, after the project phase, will manage the quality activities as operational QA (e.g. Batch Release, deviation, etc.) Key Responsibilities: Write, review and/or approve deliverables (e.g. procedures, SOPs, cleaning documents, batch documentation, gap assessments, change request, deviation and CAPA) and related data bases (e.g. training, validation) to ensure GMP compliance. Support project and maintain Sterile Production Stein line functions in GMP compliance related issues. Promote and enforce compliance to internal and external guidelines regarding quality and safety. Lead development and evaluation of new tools, processes, quality initiatives & plans, actively participate in continuous improvement. Represent Sterile Production Stein QA in inspections, audits and local and global initiatives. Ensure internal and customer support in regards to global initiatives (e.g. quality alerts) Key requirements: University or academic degree (e.g. Master) in Chemistry, Biology, Pharmacy or equivalent Professional experience in Quality Assurance or Quality Control in a manufacturing environment within Pharmaceutical Industry > 7 years Excellent knowledge of cGMP regulations Sound knowledge in manufacturing of chemical and biological drug products Problem solving skills Sets clear priorities for task for him Customer oriented and collaboration with Process Unit team Ensuring cGMP and regulatory compliance of all relevant operations in the Process Unit Excellent English skills (spoken and written) German is an advantage Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59178Apply Switzerland, Stein
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06.05.2024

Lonza AG

Plant Engineer HVAC, Clean and Black Utilities 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten. Als Betriebsingenieur Heizung-Lüftung-Klima (HVAC) und Utilities sind Sie verantwortlich für den GMP-gerechten Betrieb und die Instandhaltung der Lüftungs- und Klimaanlagen sowie der Utilites Systeme des Herstellbetriebes. Ihre Aufgaben: Technische Verantwortung für HVAC- und Utilities-Systeme, z.B. zur Erzeugung und Verteilung von WFI, Purified Water, Reindampf und Reinstgasen gemäß GMP- und EHS-Anforderungen Mitarbeit in Projekten als Fachexperte durch Bereitstellung aller erforderlichen technischen Informationen Präsentation der zugewiesenen Systeme bei Kunden- und Behördenaudits Bearbeitung von Abweichungen, CAPAs und Änderungskontrollen Leitung funktionsübergreifender Projektteams aus Technikern und Mechanikern Überprüfung und Genehmigung von Re-Qualifikationsdokumenten Ihr Anforderungsprofil: Hochschulabschluss oder Fachhochschulabschluss (Master/ Bachelor/ Dipl. Ing.) in Gebäudetechnik, Versorgungstechnik, Pharmazieingenieurwesen oder gleichwertig, z.B. Technikerausbildung mit mehrjähriger Berufserfahrung Erfahrung in Anlagen- und Betriebstechnik Erfahrung mit Systemen zur Erzeugung und Verteilung von WFI, Purified Water, Reindampf und Reinstgasen Erfahrung mit Kälte- und Lüftungsanlagen zur Sicherstellung von Reinraumbedingungen in der pharmazeutischen Produktion und der damit verbundenen regulatorischen Anforderungen (GMP) Sehr gute Kommunikations- und Interaktionsfähigkeiten mit verschiedenen Schnittstellen innerhalb der Betriebsorganisation Gute Englisch- und Deutschkenntnisse Gute Kenntnisse über computergestützte Systeme wie COMOS und SAP von Vorteil Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt. Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen Reference: R58284Apply Switzerland, Stein
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06.05.2024

Lonza AG

Plant Engineer aseptic Fill and Finish DPS Growth Project 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Plant Engineer DPS Growth Project 80 – 100% supporting a new sterile Drug product facility. Key responsibilities: Participate in FATs, construction walkdowns, C&Q to allow a smooth hand-over of Process Equipment’s After Handover ensure the operation and the correct execution of all maintenance activities of the process equipment in compliance with Safety and cGMP requirements Carries out all activities to maintain complete and up-to-date system documentation Support risk analysis and establish Sops and work instructions for the new facility and equipment in the area of responsibility Maintaining qualification status (regarding safety and cGMP) of the assigned areas Consistent recording and maintaining data of functional locations, equipment and spare parts, spare part lists, instruction manuals and SOPs, etc. Maintaining history and records in SAP and actual status of plant PIDs Ensures deviation and change management across its entire area of responsibility. Represents facility during inspections and audits as SME for area of responsibility Responsibility for one area of clean media (Clean Steam, WFI...) Key requirements Academical degree in engineering or comparable in economics with a technical focus (HF, FH, Dipl. Ing. / M. Sc. / B. Sc.) Strong technical understanding Significant work experience in Engineering and Operations within Pharma Industry Good knowledge of SAP-PM and MS Office Knowledge of GMP compliance requirements preferred Strong analytical skills with the ability to define metrics (KPI’s) and identify issues Fluency in German and English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R58330Apply Similar JobsR60327 Switzerland, Stein
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06.05.2024

Lonza AG

Operator/in 80-100% (m/w/d)

  • Lonza AG

  • Stein

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten. Am Standort Stein entsteht ein neues Produktionsgebäude im Bereich Fill-Finish. Für dieses suchen wir für die Projektphase und die anschliessende Routine-Produktion eine motivierte und belastbare Person als Operator/in Sterilproduktion. Starten Sie noch heute Ihre Karriere bei Lonza und bewerben Sie sich als Operator/in. Wichtig zu wissen ist, dass bis 2026 die Position nur Tageschichten umfasst, während sich dies im Jahr 2026 in eine 2-Schicht umwandelt. Ihre Aufgaben in der Projektphase: Unterstützung des Projektteams beim Definieren und Aufsetzen von Prozessen im Bereich der Sterilproduktion. Mitarbeit bei Qualifizierungen und Validierungen der neuen Produktionsbereiche und - prozesse. Ihre Aufgaben in der Routine: Beherrschung und Einhaltung der relevanten SOPs und Vorschriften (z. B. Hygienekonzept, Sicherheitsvorschriften, etc.) Selbstständige Bedienung von der ihr/ihm anvertrauten Teile der Produktionsanlage und Geräten inkl. deren Vor- und Nachbereitung gemäss SOP Abwicklung von mikrobiologischem Umgebungsmonitoring, In Prozess Kontrollen (IPC) und Musterzügen. Erkennung und Meldung potentieller Probleme sowie aktive Mithilfe an kontinuierlichen Verbesserungsprozessen. GMP-konformes Arbeiten und zeitgerechte Dokumentation der durchgeführten Arbeiten (e.g. Computersystemen (MES) oder Log-Bücher) Verwaltung/Reinigung/korrekte Lagerung/Überprüfung vom Equipments. Ihr Anforderungsprofil: Abgeschlossene Berufslehre im pharmazeutischen Bereich und/oder mehrjährige Arbeitserfahrung in der pharmazeutischen Produktion Erfahrung in der Anlagenbedienung und im GMP Bereich/Reinraum Hohes Sicherheitsbewusstsein Fliessende Deutschkenntnisse, Englischkenntnisse von Vorteil Bereitschaft zur Schichtarbeit Flexibilität Lonza’s Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt. Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen. Reference: R56586Apply Switzerland, Stein
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06.05.2024

Lonza AG

(Senior) Automation Engineer 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 06.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Automation (Senior) Engineer 80-100% supporting a new sterile Drug Product facility. According to the experience of the candidate and the internal guideline, this position can be either an engineer or senior engineer level. Key responsibilities: m Technical expert in Siemens TIA Portal, Zenon, AVEVA PI (former OSIsoft PI) and associated electrical knowledge. Able to take technical decisions concerning these systems. DeltaV knowledge is a plus. Technical knowledge on facilities, utilities and secondary manufacturing process equipment, including filling line, freeze dryers, isolators, automatic visual inspection, autoclave, HVAC As System Owner, ensures availability and cost-optimized operational engineering of the computerized systems of the assigned plant Provide technical SME (Subject Matter Expert) support/training to others department (included Manufacturing, Engineering, CSV, MSAT, MES or Quality) for the operation of automated equipment Ensuring and complying with cGMP procedures (included operational SOP, GAMP5, and Data Integrity ALCOA+) EHS (Environment, Health & Safety) directives and Lonza standard Lead troubleshooting and technical analyses on manufacturing equipment and process automation systems (software, electrical and OT) Ensure the continuous improvement of the systems using data and through Lonza’s network collaboration Engineer the future of the plant (industry 4.0, robots, etc.) Key requirements: Degree in Electrical Engineering or Automation or Industrial IT (HF, FH, Dipl. Ing. / M. Sc. / B. Sc.) significant experience in Siemens (TIA Portal) and/or Zenon Experience in vertical integration on plant level (PLC, ThinClient, SCADA, DCS) Experience in Secondary Manufacturing and working with major package unit suppliers (filling line, isolator, freeze dryers, washing machine, autoclave) Experience on working in GMP Environment Fluency in German and English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R57657Apply Similar JobsR56561R60188 Switzerland, Stein
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04.05.2024

Lonza AG

Team Lead QA Qualification and Validation 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 04.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Qualification and Validation 80-100% (m/f/d) being responsible to lead the QA qualification and validation team for our Strategic Growth Project in Lonza DPS Stein. Key responsibilities: Act as QA Point of Contact providing Quality Oversight for all equipment and system qualification and validation executed for the DPS growth projects Lead, build and manage a team of QA qualification, validation, CSV and DI experts and develop the team according to Lonza policies Ensure the proper qualification, requalification and validation of equipment/infrastructure/computerized-systems by adherence to the corresponding VMP(s), calibration and maintenance plans and to Lonza local quality procedures Supervise compliance activities like GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAs, audit/inspection/self-inspection observations, document management; vendor change notification; participation in audit/inspection/self-inspection Collaborate with other sites and global teams to improve and align the CQV processes within Lonza Act as first contact concerning compliance issues for equipment/infrastructure/computerized-systems qualification in shared global systems (e.g. LIMS, DMS, SAP, COMOS, Unifier, Trackwise) Work with the DI experts on site to continuously improve the DI Maturity Level of the DPS growth projects Key requirements: Academical degree (Bachelor or higher) in a Life Sciences, Engineering; IT Systems, Industrial Engineering or related science discipline Minimum of 10 years of experience in qualification and validation within a GMP regulated environment Significant working experience in a QA role within the pharma industry Strong leadership skills (strong team orientation) and ability to communicate internally and externally at higher levels, strong business understanding Aseptic production experience is desired Data Integrity mindset is a must Fluency in English and German Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R56985Apply Switzerland, Stein
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03.05.2024

Lonza AG

Supply Planner DPS Growth Project 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 03.05.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Supply Planner DPS Growth Project 80-100% (m/f/d) being responsible for a new sterile Drug product facility in a Capital investment project Key responsibilities: Execute the monthly supply planning cycle including the creation and updating of supply plans and identification of key supply decisions People leading of a team of 2-5 Ensure input from all relevant stakeholders are incorporated into supply plan Assure and implement control in managing raw materials and finished goods inventory to prevent losses and/or scrap Prepare supply planning input into monthly S&OP cycle and annual budget cycle Create and maintain supply related KPIs and use as basis for supply planning improvement initiatives Liaise with all relevant stakeholders and functions to ensure supply plan represents consensus view of future supply plans and actions Ensure supply plan is inputted and maintained in relevant supply systems including SAP IBP and SAP ECC Ensure Supply Plans is used to drive related material, labor and asset capacity plans Key requirements: Academical degree (Bachelor or higher) in Supply Chain Management or equivalent study field Substantial working experience in supply chain in a pharmaceutical company proven knowledge of cGMP compliance requirements strong analytical skills with the ability to define metrics (KPI’s) and identify issues through root cause analysis Fluency in English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59904Apply Switzerland, Stein
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28.04.2024

Lonza AG

(Senior) Automation Engineer HVAC-Utilities 80 - 100% (m/f/d)

  • Lonza AG

  • Stein

  • 28.04.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior Automation Engineer HVAC-Utilities 80 – 100% supporting a new sterile Drug Product facility. According to the experience of the candidate and the internal guideline, this position can be either an engineer or senior engineer level. Key responsibilities: Technical expert in process HVAC and Utilities (Black & Clean) Technical expert in Emerson Delta V, AVEVA PI (former OSIsoft PI) and associated electrical knowledge. Able to take technical decisions concerning these systems. Technical knowledge on Building Management System Provide technical SME (Subject Matter Expert) support/training to others department (included Manufacturing, Engineering, CSV, MSAT, MES or Quality) for the operation of automated equipment Ensuring and complying with cGMP procedures (included operational SOP, GAMP5, and Data Integrity ALCOA+) EHS (Environment, Health & Safety) directives and Lonza standard Lead troubleshooting and technical analyses on manufacturing equipment and process automation systems (software, electrical and OT) Ensure the continuous improvement of the systems using data and through Lonza’s network collaboration Engineer the future of the plant (industry 4.0, robots, etc.) Key requirements: Degree in Electrical Engineering or Automation or Industrial IT (HF, FH, Dipl. Ing. / M. Sc. / B. Sc.) Significant experience in automation engineering and maintenance, ideally in operation of a pharmaceutical company Significant experience in Emerson DeltaV Significant experience in HVAC and Utilities Knowledge of GMP compliance requirements preferred Fluency in German and English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R60188Apply Similar JobsR56561R57657 Switzerland, Stein
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27.04.2024

Lonza AG

Instandhaltungsmechaniker 80-100% (m/f/d)

  • Lonza AG

  • Stein

  • 27.04.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten. Unser erfolgreicher CDMO-Geschäftsbereich Drug Product Services (DPS) mit Sitz in Stein, Schweiz, bietet derzeit spannende Möglichkeiten. Werden Sie Teil einer Gruppe, die es ihren Kunden ermöglicht, einige der grössten Herausforderungen in der Patientenbehandlung zu meistern. Bewerben Sie sich bei uns als Industriemechaniker 80 – 100% (m/f/d) Ihre Aufgaben: Technisches Bereitstellen von Produktionsanlagenanlagen im Bereich der sterilen Abfüllung und Gefriertrocknung nach GMP-Richtlinien. Instandhaltung und Störungsbehebung im mechanischen und elektrischen Bereich an technisch anspruchsvollen Anlagen Arbeiten in Reinraumzone unter Einhaltung entsprechender Vorschriften Kontinuierliche Optimierung der Maschinen, Anlagen, Instandhaltungsprozessen und internen Abläufen Einhaltung gültiger Standards hinsichtlich Sicherheit, Hygiene, Umwelt, Qualität Ordnungsgemässe Durchführung und sorgfältige Dokumentation aller Tätigkeiten (Logbücher, SAP) Ihr Anforderungsprofil: Ausbildung zum Polymechaniker oder gleichwertiger technischer Bildungsweg Verständnis für komplexe Produktion und Infrastrukturanlagen im GMP-Bereich von Vorteil Sehr gute Kommunikations- und Interaktionsfähigkeiten mit verschiedenen Schnittstellen innerhalb der Betriebsorganisation Idealerweise erste Berufserfahrung in Anlagen- und Betriebstechnik (bevorzugt im Pharmabereich) Gute MS Office Kenntnisse Sehr gute Deutschkenntnisse und Grundkenntnisse Englisch Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt. Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen. Reference: R59782Apply Switzerland, Stein
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26.04.2024

Lonza AG

MSAT Expert Drug Product 80 - 100% (m/f/d)

  • Lonza AG

  • Stein

  • 26.04.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and apply for the position as MSAT Expert where you will be responsible for successful drug product and manufacturing process transfers as well as implementation at the manufacturing site. Join us to lead projects to improve and expand manufacturing capabilities across our DPS network. Key Responsibilities: Participate in GMP risk analysis for the manufacturing processes and Contamination Control Strategy of the facility Contribute to the development and implementation of standardized MSAT procedures and processes (e.g. qualification standard and strategy, single use system...) Partake in cross-functional teams as MSAT Expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale Support new product introduction by evaluating/developing ‘fit for purpose’ processes Take care of process monitoring and process control strategy as well as complex data analysis Own concepts on site or across the DPS network continuously improving in quality and efficiency in compliance to cGMPs, SOPs, EHS and applicable guidelines Lead Performance qualification activities for new equipment, filling line or a facility and support Process Performance Qualification of Biologics License Application projects Lead complex product and process related investigations and deviations including complaints actions and resolve technical challenges within area of expertise. Maintain processes at Inspection readiness level and to provide the necessary support in any internal or external audits as well as in Back/Front office or in facility tours Key requirements: University degree preferably in Biotechnology, Chemistry, Pharmacy, Engineering, Pharmaceutical Technology or equivalent scientific degree / equivalent experience Working experience in aseptic drug product manufacturing (clinical product and/or commercial product) Proven process and regulatory understanding in Sterile Manufacturing, cGMP and writing SOPs IT knowledge in SAP or MES is an asset Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor Experience in international inspection / audit is an asset Fluency in English, German is an asset Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R57453Apply Switzerland, Stein
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25.04.2024

Lonza AG

Process Expert automated visual inspection - DPS Growth Project

  • Lonza AG

  • Stein

  • 25.04.2024

  • Festanstellung 100%

Festanstellung 100%

Stein

Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. As a Member of the Operations Team in a Capital investment project, the Process Expert (PE) provides front line expertise for operational activities within one or more production steps and equipment, with respect to safety, quality and on-time full delivery. Become part of this exciting opportunity and apply now! Key responsibilities: Establish, drive and maintain good CNC room management practices Own and provide expertise to the two automated visual inspection lines, operational activities and project ramp-up Execute and support validation and qualification incl. all relevant documentation Create, update and own change request on standard operating procedures and electronic batch records Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures Maintain the assigned processes/equipment at Inspection readiness level and provide the necessary support in any internal or external audit Support the goal of executing each batch safely, in time, in compliance with the quality requirements Support innovation and future implementation of artificial intelligence (AI) based inspection Support the team leader as deputy Key requirements: MSc. in Pharmaceutical Technology, Pharmacy, Engineering or equivalent scientific degree / equivalent experience First experience in pharmaceutical aseptic production for drug product manufacture especially in automated visual inspection Good understanding of vision engineering or image analysis Strong understanding of regulations and good manufacturing practices relevant to aseptic manufacture of sterile drug products Experienced in ramping up new production facility or new lines Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels Flexible, able to respond to daily changing demands Effective communicator, verbal and written Fluency in German and English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R59110Apply Switzerland, Stein
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22.04.2024

Lonza AG

Operator Abfüllung im 2-Schichtbetrieb 80-100% (m/w/d)

  • Lonza AG

  • Stein

  • 22.04.2024

  • Festanstellung 80-100%

Festanstellung 80-100%

Stein

Switzerland, Stein Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten. Für unsere erfolgreiche CDMO-Unternehmensgruppe (Auftragsentwicklung und –Herstellung) Drug Product Services (DPS), in Stein, Schweiz, suchen wir stetig die besten Talente. Werden Sie Teil einer Unternehmensgruppe welche Ihre Kunden befähigt einige der grössten Herausforderungen modernen Patientenbehandlung zu meistern. Starten Sie noch heute Ihre Karriere bei Lonza und bewerben Sie sich als Operator/in Sterilproduktion (Abfüllung). Ihre Aufgaben: Sicherstellung der reibungslosen Durchführung von Prozessen/Abläufen Erkennung und Meldung potentieller Probleme Beherrschung und Einhaltung der relevanten SOPs und Vorschriften (z. B. Hygienekonzept, Sicherheitsvorschriften, etc.) Vorbereitung und Prüfung der flüssigen Produkte sowie Bedienung der Abfülllinie und Durchführung benötigter Eingriffen Selbstständige Bedienung von Anlagen und Geräten inkl. deren Vor- und Nachbereitung gemäss SOP Abwicklung von mikrobiologischem Umgebungsmonitoring, In Prozess Kontrollen (IPC) und Musterzügen GMP-konformes Arbeiten und zeitgerechte Dokumentation der durchgeführten Arbeiten (e.g. Computersystemen (MES) oder Log-Bücher) Verwaltung/Reinigung/korrekte Lagerung/Überprüfung vom Equipments Ihr Anforderungsprofil: Abgeschlossene Berufslehre im pharmazeutischen Bereich und- oder mehrjährige Arbeitserfahrung in der pharmazeutischen Produktion Erfahrung in der Anlagenbedienung und im GMP Bereich/Reinraum Gute EDV-Kenntnisse; MES und SAP von Vorteil Einwandfreie stufengerechte Kommunikation mit internen Schnittstellen (Betrieb, QA, QC und Engineering, Supply Chain) Fliessende Deutschkenntnisse, Englischkenntnisse von Vorteil Strukturierte, fokussierte und organisierte Arbeitsweise, Durchsetzungskraft und motiviert, selbständig arbeitend, flexibel und belastbar Bereitschaft zur Schichtarbeit (2 Schichtbetrieb, Mo - Fr 06:00 - 14:00 / 14:00 - 22:00 Uhr, teilweise Samstags)* *Arbeitszeiten sind mit Vorbehalt zu betrachten, es kann zu Abweichungen kommen Lonza’s Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt. Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen. Reference: R59236Apply Switzerland, Stein
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