Engineer Mfg Science Drug Substance // 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.

The aim of the position is to support the bacterial vaccine Launch project for a first GMP commercial production with focus on Downstream process step on large scale of 200L.

Main Responsibilities

• Writing GMP process documents like MBR, Work Instructions, Equipment manuals and Process Risk assessments
• Writing of electronical Batch Records will be one of the main tasks at the beginning
• Train Operators on written process documents
• Support PPQ (Process Performance Qualification)
• Managing of Quality Issues, Root Cause Analysis and Investigations
• Data verification
• Data trending