- The CSV Engineer will support management of CSV re-qualification in a first of its kind facility in Ireland
- Support the CSV requirements for site production and laboratory systems.
- Provide CAPEX team with adequate validation support at all times.
- Review vendor documents to support commissioning and qualification requirements.
- The CSV Engineer will complete the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
- Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
- You will also support Technology Transfer initiatives for new incoming biologics products
The next CSV Engineer should have a degree in Science or Engineering with at least 3 years CSV experience.
You should have a strong working knowledge of validation practices including 21CFR Part 11 requirements, ER/ES and data integrity guidelines
If you're looking to work with an innovative biopharma client in a first of its kind facility in Ireland then get in touch now!
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