Beschreibung
Process Engineer (Vaccines)Our pharmaceutical client is looking for an experienced Process Engineer to help with the set-up of a process engineering team for the vaccines production department.
This is a dynamic and challenging assignment with a “hands on” approach and requiring a strong coach/mentor and excellent communicator.
Key requirements:
• Responsible for the validation of the manufacturing process for a mammalian cell-culture product to be manufactured using disposable equipment.
• Manage the introduction of new vaccines products from clients.
• Support the transition of vaccines products from development to manufacturing.
• Aseptic processes to be validated include filtration, fermentation, fill/finish and packaging.
• Writing of validation documentation for the clean room, equipment and processes.
• Data and Risk analysis for validated processes.
• Support the internal and external audit efforts.
• Involvement and general support to the product transfer group including execution of assigned projects.
Qualifications/Requirements:
• Extensive experience in a Biologics, specifically vaccines environment and the mammalian cell culture processes.
• Strong experience and knowledge of process engineering and validation.
• Experience in clinical development of a product is advantageous.
• Knowledge of Risk assessment and management through data analysis.
• Knowledge of biopharmaceutical FDA and GMP quality standards/regulatory requirements.
• English + German language skills essential.