SIP VALIDATION SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer.
The SIP VALIDATION SPECIALIST will be involved in the review and approval of SIP thermal mapping and Performance Qualification validation protocols, extensive experience on writing and approving Deviations required.
Role of this position
- Experience in Validation specifically cleaning validation and thermal mapping.
- Experience in assessment of cleaning issues during study runs,
- Placement of thermocouple probes in vessel and transfer lines.
- Experienced Technical writer,
- Experience in Deviation/Change control writing,
- Capable of managing a large program, so project management skills would be necessary,
- An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment/ Theemal maapping works.
- Troubleshooting of thermal mapping studies for investigation and Engineering studies.
- Understanding of baseline studies for new equipment.
- Experienced in coverage testing and clean-into-service.
- Generate/review/Approval of CV/ SIP protocols,
- Generate Reports.
- Maintain and update Cleaning/ Steam in place Validation Plan.
- Schedule of cleaning/SIP activities with Manufacturing.
- Liaise with numerous departments.
- Ideally looking for 3-5 years Biotech cleaning/SIP validation experience
- Experience in Document Preparation and Execution
- Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning and SIP validation studies may be concurrent activities in different trains.
- Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
- Have Troubleshooting and analytical mindset.
Please call Conor Twomey today for further information on 021 4297422 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)