Great opportunity for an experienced QA Cleaning Validation Specialist to work onsite with our biotech client in Limerick in their Cleaning Validation team on a shift basis. As QA Cleaining Validation Specialist you will be completing documentation for execution of cleaning validation quailifcations studies and investigations and report generation for activities for the Cleaning Validation Program at the Limerick based biotech facility.
As QA Cleaning Validation Specialist you will be responsible for:
o Taking Cleaning Validation samples alongside Upstream/Downstream processing.
o Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
o Generating and Executing Validation Protocols.
o Actively look for Continuous improvements
o Generate/review/Approval of CV protocols,
o Generate Reports
o Maintain and update Cleaning Validation Plan
o Schedule of cleaning activities with Manufacturing
As QA Cleaning Validation Specialist you will have:
o BSc or BEng
o 3 + years Biotech experience in Validation specifically cleaning validation
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 aseptic technique
o Experience in Gowning for IOS7/ISO8
o Experience in assessment of cleaning issues during study runs,
o Experienced Technical writer,
o Experience in Deviation/Change control writing,
o Capable of managing a large program, so project management skills would be necessary,
For full details on this role please contact Kathy on 021 4777329 or apply directly through this advert.