Description
Validation EngineerOur biopharmaceutical manufacturing client has undertaken a large expansion of its manufacturing facilities to allow for its first commercial production runs. The equipment and process engineering team is currently looking for a validation engineer to support them with validation of new and existing equipment. You will be involved with autoclave and washer validation, including writing and executing site validation protocols.
Location: Düsseldorf Germany
Duration: Initial 6 months contract
The Role:
- Validation of autoclaves, including thermal mapping utilising the Kaye Validator.
- Validation of washers which will include taking swab and rinse samples and analysis of test results.
- Supporting the team with qualification and validation of other new and existing equipment including upstream and downstream process equipment.
- Writing, executing and reviewing of site validation protocols.
Requirements:
- Previous experience in the pharmaceutical essential.
- Experience of validation of autoclaves including thermal mapping is required.
- Knowledge and experience with the Kaye validator system.
- Washer validation experience required, including taking of swab and rinse samples.
- Knowledge of GMP and FDA requirements.
- Proven ability in executing and writing validation documentation.
- Experience working to tight project schedules and deadlines.
- Both a strong team player and able to work independently.
- English fluent, German language skills are desired.