Engineer Manufacturing Material // Johnson & Johnson
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 Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.
Johnson & Johnson Innovative Medicine is a global pharmaceutical 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. 600 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.Main Responsibilities
- Manage projects and activities related to materials compliance (Material assessment for new product introduction)
- Serve as liaison between Suppliers, Material science and Supplier Quality and the users from early stages of Development for introduction of new Materials intended to use for GMP processes
- Act/serve as a liaison between all functions including suppliers, materials science, supplier quality, and end-users from the early stages of development for the introduction of new materials intended for use in GMP processes
- Ensure materials compliance with user requirements
- Understanding biotechnology processes to ensure materials comply with GMP production user requirements
- Change Control owner for Material Qualification
- 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 Supplier Quality)
- Coordinate material Leachable & Extractable evaluation
- Coordinate the implementation of alternative/back up materials, dual sourcing strategy in close collaboration with Business operations, Material Science, Supplier Quality, Operations and Development
- Support the site during audits/inspection for Material topics
Who we are looking for
- A minimum of a bachelor's degree or equivalent pharma discipline
- 2+ years of 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, aseptic manufacturing, and sterility assurance
- Thorough knowledge in cleanrooms environments is a major plus
- Experience with the requirements for material qualification from R&D to Commercial
- 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 based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, inclusive and collaborative environment, then send us your application today. Or give us a call if you have any questions!
Adresse
Randstad (Schweiz) AG, c/o Johnson & Johnson
