JobdescriptionCaring 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
- Execution of the practical upstream project work within a cGMP regulated environment. To a lead technician, an implicit lead function in process execution can be assigned
- Reporting and interpretation of batch manufacturing results. Conclude on results in consultation with the process engineer or the scientist/team leader contributing to process and operational improvement
- Carry out development and manufacturing activities according to predefined study plans or batch records complying to the defined timelines
- Carry out core USP processes (small scale aseptic mammalian cell culture in roller bottles or shaker flasks, operation of small scale bioreactors (10, 20, 50 L), equipment preparation, buffer preparation, infection of cell culture using viruses, cell harvest or according to cGMP
- Support process/cleaning qualification and validation work
- Establishment and ownership of WIs/TRGs and manufacturing protolcs
- Support safety and environmental initiatives by testing equipment prior to starting production
- Perform Work according to EHS regulations, report EHS gaps and/or incidents and initiate EHS improvement
- Document the executed work in protocols and batch records according to good documentation practice
- Review filled out batch records and manufacturing protocols
- Plan the execution of work packages and manufacturing operations as well as side activities
- Perform manufacturing raw materials/consumables reservations in ERP system
- Take part in establishment and provide feedback to study plans, study reports, work instructions, MBRs, technical and equipment maintenance/calibration reports
- Report quality documentation gaps and act upon them depending on defined responsibilities
- Implementation and introduction of new processing techniques and manufacturing equipment and/or coordination of equipment improvements and modifications
- Communication with external parties for purchase of new equipment and materials
- Support equipment qualification and computerized system validation activities
- Internal organization of assigned pilot plant facility suites including implementation of safety relevant procedures as well as house-keeping activities (log books, cleaning protocols, etc.) in accordance to cGMP regulations
- Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP
Functie-eisenWho we are looking for
- BSc or MSc degree in LifeSciences or concluded apprenticeship in LifeScience with several years of professional experience
- Professional work experience in a cGMP environment is a major plus
- Flexible, adaptive and a team player
- Ability to work independently and self-disciplined to meet the given timelines
- Very good communication in German and English
This job based in Bern, Switzerland will initially be limited to 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!
Stephan Zoebeli