Qa Validation Technical Writer

The role: 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. Taking Cleaning Validation samples alongside Upstream/Downstream processing. 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. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to ******.

Please note: our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.

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