Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 400 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.
- Change Control owner for Material Qualification
- Manage projects and activities related to materials compliance (Material assessment for new project introduction)
- Serve as liaison between Suppliers, material science and ESIQ and the users from early stage of Development for introduction of new Materials intended to use for GMP processes
- Ensure compliance with user requirements for materials
- Coordinate and lead the introduction and changes of non-GxP and GxP raw materials and ancillary supplies throughout the life cycle of products produced at the Bern site
- New Material and application scouting and point of contact for selected suppliers, and global functions (Material Science and ESIQ)
- Coordinate material Leachable & Extractable evaluation
- Support in the implementation of alternative/back up materials; dual sourcing strategy in close collaboration with Business operations, Material Science, ESIQ, Operations and Development
- Support the site during audits/inspection for Material topics
Who we are looking for
- Masters degree in a LifeSciences discipline
- Work experience in a GMP environment, in a pharmaceutical, or similar regulated industry with detailed knowledge of relevant regulations and standards
- Understanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms environments is a major plus
- Experience with the requirements for material qualification from R&D to Commercial, is preferred
- Demonstrated collaborative nature and proactive communication skills to work efficiently and effectively in a diverse community on cross-functional project teams
- Excellent organizational and time management skills
This job is based in Bern, Switzerland and will initially be limited to 12 months. If you are interested in working for a global leading health care company, in a highly dynamic and flexible work environment, then send us your application today. Or give us a call if you have any questions!