Description
Our global biopharmaceutical client based in France is currently undergoing preparations for an FDA audit in 2017. Having recently moved into biologics production, the client is looking to grow their knowledge and expertise in compliance for the new products being introduced. Support is required to review current work practices and drive compliance to FDA requirements in advance of the audit.They are looking for 3 Validation Engineers to work as part of a team, each bringing their own area of expertise to review the following processes and equipment:
- Cleaning Validation
- Clean rooms
- Cleaning Processes
- Sampling Techniques
- Process Equipment Validation
- Bioreactors
- Buffer prep
- Media prep
- UF/DF
- Downstream operations - Chromatography columns
- Utilities Validation
- Gas
- C02
- Steam
- Compressed Air
- HVAC
- Re-qualification of respective equipment in your area of expertise.
- Review OQ + PQ documentation, identify gaps and deliver compliance.
- Suggest any improvements to current working practices and processes to drive an ongoing adherence to GMP/FDA regulations.
- Validation expertise within at least one of the above areas.
- Experience with validation from OQ stage.
- Experience within biopharmaceutical production environments required for equipment and cleaning validation.
- Experience in pharmaceutical or biopharmaceutical environment required for utilities validation.
- Previous experience of audit preparation is beneficial.
- French language skills will be beneficial.