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MSAT Expert Drug Product 80-100%

Lonza -
Stein, AG

Jetzt bewerben

Details zur Stelle

Pensum: 90-100%
vor 13 Tagen

Leistungen

Umzugskostenzuschus

Qualifikationen

Investment
Biotechnologie
Englisch
Bachelor
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

he actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five 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.

Become an MSAT Expert at Lonza AG for an exciting Greenfield project in Stein AG Switzerland! Support the commercial readiness of a large-scale aseptic fill&finish facility for Biologics.

What you’ll get:

An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

Key responsibilities:

Act as the MSAT Expert in capital investment projects to build and commission manufacturing units, ensuring commercial readiness for the GMP manufacturing facility.
Define qualification strategies and concepts for DP manufacturing equipment and clean rooms as part of the aseptic fill&finish lines in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a MSAT member in cross-functional project teams (e.g QA, Engineering, Manufacturing, QC).
Provide technical leadership during the design of the sterile manufacturing processes, including cleanroom layout, material/personnel flow, and equipment placement.
Craft the Aseptic Process Simulation concept in alignment with internal guidelines and regulatory requirements. Provide oversight and technical support during execution of APS and all investigations regarding the aseptic manufacturing process. Support the development of aseptic technique training programs.
Lead risk assessments (e.g FMEA) to identify critical manufacturing process parameters and control strategies for the facility. Author and review GMP documents such as Qualification/Validation master plans, protocols and reports, SOPs, manufacturing concepts, etc.
Ensure GMP documentation readiness for authority inspections in line with internal and external quality standards.
Contribute to the development and implementation of standardized MSAT procedures and processes, including qualification standards, single-use systems, and filtration systems.

Key requirements:

University Degree or equivalent technical education in Biotechnology, Pharmacy, or a related field
Significant experience in aseptic/sterile fill&finish processes of drug products in a GMP environment is a must, with substantial know-how in aseptic processing and sterility assurance principles.
Experience in at least one of the following is a must: qualification of manufacturing equipment; cleaning validation; room qualification
Strong communication skills, able to translate complex technical topics into clear actionable messages.
Proactive, positive approach, problem-solving attitude, and ability to take full responsibility for assigned areas.
Ability to lead cross-functional teams and drive decision-making in a matrix organization; build strong networks and trust across internal and external stakeholders.
Proficiency in English is a must; German language skills are a plus.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Jetzt bewerben

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