Assoc. Engineer MSIT Mfg Science Drug Substance (DSP specialist)

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 134,000 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 acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and is recently expanding its portfolio into bacterial based therapeutic products.

Main Responsibilities:

The aim of the position is to support a routine GMP manufacturing process with focus on Downstream process steps (chromatography, Diafiltration/Ultrafiltration).

• Support routine GMP manufacturing and help in trouble shooting and process improvements
• Data verification
• Data trending
• Writing of SOP's (first draft MBR's, WorkInstructions, Equipment handling) and train Operators on those documents
• Writing of Reports (TechTransfer/Campaign) and Technical documents like Risk Assessments
• SME (Subject Matter Expert) for Quality Issues, Root Cause Analysis and Investigation
• Initiating and implementing of Change Controls