The role:
PE Global is currently recruiting for numerous QA Cleaning Validation Engineers on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.
Responsibilities:
1. Execution of cleaning validation protocols.
2. Taking Cleaning Validation samples alongside Upstream/Downstream processing.
3. Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
4. Generate/review/Approval of CV protocols,
5. Generate Reports
6. Maintain and update Cleaning Validation Plan
7. Schedule of cleaning activities with Manufacturing
8. Liaise with numerous departments
9. Ensure Training is maintained and current.
10. Follow all EHS/Safety SOP/Policies
11. Actively look for Continuous improvements
Experience:
12. Experienced in QA Validation activities –
13. Extensive experience on writing and approving Deviations/GMP documents
14. Technical writing experience in writing site reports
15. Experience in aseptic technique
16. Experience in Gowning for IOS7/ISO8
17. Generating and Executing Validation Protocols.
18. Experience in Validation specifically cleaning validation
19. Experience in assessment of cleaning issues during study runs,
20. Experienced Technical writer,
21. Experience in Deviation/Change control writing,
22. Experienced in coverage testing and clean-into-service
Interested candidates should submit an