Lead Technician GMP Operations // Johnson & Johnson
Posted: 06 Feb 2024
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
- Planning, executing and documenting assigned project work (USP) with established procedures (MBRs, SOPs) according to good documentation practice and corresponding regulations (cGMP, ICH). To a lead technician an implicit lead function in process planning and execution can be assigned.
- Carrying out core USP processes (fermentation, separation, depth filtration, buffer preparation, equipment cleaning/setup/prep, etc.) and complying to cGMP regulations.
- Organizing the lab (GMP area), including safety procedures and troubleshooting if needed. Reporting of EHS gaps and/or incidents and initiation of EHS improvements.
- Internal organization of assigned pilot plant facility suites including implementation of safety relevant procedures as well as admin activities (logbooks, cleaning protocols, etc.) according to cGMP regulations.
- Establishing and owning Work instructions and manufacturing protocols.
- Documenting the executed work in protocols and batch records in accordance with good documentation practice, report documentation gaps and act upon them depending on defined responsibilities.
- Accurate interpretation of batch manufacturing results/data. Concluding on results with the process engineer or the scientist/team leader thus contributing to campaign reporting and to process and operational improvements.
- Communicating with internal and external parties for raw material supply as well as for purchasing and commissioning new equipment.
- Supporting process/cleaning qualification, validation work and equipment qualification and computerized system validation activities.
- Supporting equipment qualification and computerized system validation activities.
- Implementing new techniques and technologies, staying up to date with novel technologies related to the work area, maintaining a spirit of continuous improvement.
- Key role in writing MBRs and work instructions.
- Supporting the establishment and feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports.
- Initiating quality issue records and low impact investigations as well as corrective actions.
- Initiating Change controls and CAPAs.
- Executing Batch record review I (BRRI).
Who we are looking for
- University degree in life sciences OR apprenticeship in the field of LifeScience with several years of professional experience
- Advanced kledge of USP technology, cell and virus cultivation and bacterial fermentation is a major plus
- Flexible, adaptive and a team player.
- Open for flexible working time
- od level of communication in German and English.
- Kledge on problem solving and communication.
- Ability to work independently and self-disciplined to meet the given timelines.
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, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!