The CSV Engineer reports to the Engineering Services Manager and will participate in:
All Computerised System Validation (CSV) activities on site, along with periodic re-qualification requirements.
Provide CSV support to capital projects that are executed on site.
- Support the CSV requirements for site production and laboratory systems.
- Support the management of ongoing CSV re-qualification requirements.
- The CSV Engineer will work cross functionally to develop and deliver the annual CSV re-qualification requirements.
- Provide CAPEX team with adequate validation support
- Review vendor documents to support commissioning and qualification requirements.
- Completes 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.
- As required. support the Technology Transfer initiatives for incoming new products.
- Participate fully in cross-functional training initiatives.
The next CSV Engineer should have a 3rd level Engineering or Science Degree with at least two years validation experience (CSV) within a pharmaceutical setting.
Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
If you’re looking to join one of Ireland most exciting biopharma start-up facilities then get in touch now to hear more!
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