The Role:
PE Global is recruiting for QA Cleaning Validation Engineers on behalf of a leading biotech company in Limerick. This is an initial 12-month contract role.
Key Responsibilities:
* Execute cleaning validation protocols.
* Take samples alongside upstream and downstream processing.
* Work closely with manufacturing to ensure correct CIP/SIP times and sample collection.
* Develop, review, and approve CV protocols.
* Generate reports.
* Maintain and update the cleaning validation plan.
* Schedule cleaning activities with manufacturing.
* Liaise with multiple departments.
* Ensure up-to-date training and EHS compliance.
* Continuously improve processes.
Essential Experience:
* Proven experience in QA validation.
* Extensive experience in writing and approving deviations and GMP documents.
* Technical writing expertise, including site reports.
* Aseptic technique experience.
* Gowning experience in ISO7/ISO8 environments.
* Generating and executing validation protocols.
* Cleaning validation experience.
* Assessing cleaning issues during study runs.
* Experienced technical writer.
* Deviation/change control writing experience.
* Coverage testing and clean-in-service experience.