Job Description
CLEANING VALIDATION SPECIALIST with rinse & swab experience required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer.The CLEANING VALIDATION SPECIALIST will have experience in the execution of cleaning validation protocols, experience on writing and approving Deviations/ GMP documents and Technical writing experience in writing site reports.
Role of this position
1. Taking Cleaning Validation samples alongside Upstream/Downstream processing.
2. Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
3. Experience in aseptic technique
4. Experience in Gowning for IOS7/ISO8
5. Generating and Executing Validation Protocols.
6. Actively look for Continuous improvements
7. Experience in Validation specifically cleaning validation
8. Experience in assessment of cleaning issues during study runs,
9. Experienced Technical writer,
10. Experience in Deviation/Change control writing,
11. Capable of managing a large program, so project management skills would be necessary,
12. Generate/review/Approval of CV protocols,
13. Generate Reports
14. Maintain and update Cleaning Validation Plan
15. Schedule of cleaning activities with Manufacturing
JOB REQUIREMENTS
16. Degree qualified in Science / Engineering discipline
17. At least 2 years Cleaning Validation experience in the pharmaceutical or Biotechnology setting.