Beschreibung
Qualification/Validation EngineerOur biopharmaceutical manufacturing client has undertaken a large remodelling project of its manufacturing facilities to allow for its first commercial production runs. The equipment and process engineering team is currently looking for a Qualification/Validation engineer to support them with a number of remediation projects to get the site ready for FDA inspection.
Job and Project Description
- Support on an ongoing remediation programme to review qualification, validation and other production documentation.
- Gap analysis of existing documentation for compliance with GMP, FDA and client internal guidelines.
- Hands on writing and review of documentation.
- Support in developing ongoing strategies for qualification and validation of equipment and automation systems.
- Generation of qualification and validation plans and reports.
- Completion of existing qualification remediation activities.
- Work closely with the existing qualification/validation team.
- Comprehensive knowledge of technical and regulatory compliance requirements including GMP and FDA.
- Comprehensive understanding of manufacturing in the (bio-)pharmaceutical industry.
- Strong experience of qualification of pharmaceutical manufacturing equipment ideally including one or more of:
- Upstream Biopharmaceutical equipment.
- Downstream Biopharmaceutical equipment.
- Clean rooms.
- Autoclaves.
- Soft skills: team player; hands on and task orientated approach; self-dependent; strong problem solving abilities.
- English and German language essential in written and spoken form.