PE Global is currently recruiting for numerous QA Cleaning Validation Engineers on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.
Responsibilities:
* Execution of cleaning validation protocols.
* Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
* Generate/review/Approval of CV protocols.
* Generate Reports.
* Maintain and update Cleaning Validation Plan.
* Schedule cleaning activities with Manufacturing.
* Liaise with numerous departments.
* Ensure Training is maintained and current.
* Follow all EHS/Safety SOP/Policies.
* Actively look for Continuous improvements.
Experience:
* Experienced in QA Validation activities.
* Extensive experience in writing and approving Deviations/GMP documents.
* Technical writing experience in writing site reports.
* Experience in aseptic technique.
* Experience in Gowning for ISO7/ISO8.
* Generating and Executing Validation Protocols.
* Experience in Validation specifically cleaning validation.
* Experience in assessment of cleaning issues during study runs.
* Experienced Technical writer.
* Experience in Deviation/Change control writing.
* Experienced in coverage testing and clean-into-service.
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