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 265 operating companies in more than 60 countries employing approximately 120,000 people.

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. 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, execution and documentation of assigned project work (DSP) with established procedures (MBRs, SOPs) according to good documentation practice and corresponding regulations (cGMP, ICH)
• Carry out core DSP processes (chromatography, tangential flow filtration, chromatography column packing, depth filtration, sampling, buffer preparation, equipment cleaning/setup/prep, etc.) complying to cGMP regulations
• Organization of the lab (GMP area), including safety and 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 house-keeping activities (logbooks, cleaning protocols, etc.) in accordance with cGMP regulations
• Establishment and ownership of SOPs and manufacturing protocols
• Document 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
• Reporting of non-conformances
• Communication with internal and external parties for raw material supply as well as for purchasing and commissioning of 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
• Support in establishment and providing feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports
• Ordering of material and equipment, participation in the management of the internal storage location
• Overview of material availability and tracking of open orders including reservations, orders and bookings in SAP

Who We Are Looking For

• Apprenticeship or Bachelor degree in a LifeScience field (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent)
• Experience in working in a clean room environment
• Knowledge of DSP technology, chromatographic and diafiltration techniques and equipment is a plus
• Flexible, adaptive and a team player
• Good Communication in German or English
• Knowledge on problem solving and good communication skills
• 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!