Great opportunity for an experienced Cleaning Validation Specialist to work onsite with our biotech client in Limerick. As SIP/Cleaining Validation Specialist you will be performing document preparation and field execution activities for the Cleaning/SIP Validation Program.
The Cleaning Validation Specialist will be responsible for:
o Execution of cleaning validation and thermal mapping
o Assessment of cleaning issues during study runs,
o Placement of thermocouple probes in vessel and transfer lines
o Troubleshooting of thermal mapping studies for investigation and Engineering studies
o Maintain and update Cleaning/ Steam in place Validation Plan
o Schedule of cleaning/SIP activities with Manufacturing
o Generate/review/Approval of CV/ SIP protocols, and Reports
o Actively look for Continuous improvements
o Liaise with numerous departments
The Cleaning Validation Specialist will require:
o BSc or BEng
o 3+ years Biotech experience in /Cleaning Validation/Cleaning equipment/ Thermal mapping
o Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning validation studies may be concurrent activities in different trains.
o Experience in coverage testing and clean-into-service and understanding of baseline studies for new equipment
o Experienced Technical writer skills and experience in Deviation/Change control writing,
For full details on this role, please contact Kathy on 021 4777329 or firstname.lastname@example.org on apply directly through this advert.