Description
Validation Engineer - LaboratoryOur biopharmaceutical manufacturing client is currently preparing for its first FDA audit to obtain the approval for manufacturing of its first product. The QC department is preparing for the audit and requires an additional candidate to carry out gap analysis on existing documentation, validate laboratory equipment and complete all related documentation.
Duration: 6 months
Location: Düsseldorf region, Germany
Job Description
- Supporting the laboratory validation team with qualification and validation of existing equipment.
- Writing of IQ / OQ/ PQ and execution of the protocols.
- The equipment requiring validation includes:
- Temperature validation
- HPLC
- Analytical measurement instruments
Requirements:
- Previous experience in the pharmaceutical or medical device industry essential.
- Knowledge of GMP requirements.
- Previous experience with qualification of laboratory equipment required.
- Experience of validation of the above equipment a distinct advantage.
- Proven ability to establish collaborative working relationships; team-oriented and must be able to work independently.
- Personal attributes include flexibility, integrity, action- and goal-oriented.
- German language skills essential.