Cleaning Validation - SIP Specialist
A Cleaning Validation Specialist with strong Steam In Place experience is required for a Munster based Biopharmaceutical multinational. The successful candidate will complete document preparation and field execution activities for the Cleaning Validation Program at the BioTech facility
- 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/ Thermal mapping 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
Qualifications and Experience:
- 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.
For more information contact Nicola on 0870622429 or email your CV in the strictest confidence to email@example.com