CQV Engineer - Fill Finish - Pharmaceuticals
We are seeking a CQV Engineer to support multiple capital projects at our site in Leinster.
Job Description
This is a unique opportunity to work on a cutting-edge fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Key Responsibilities:
* Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilisation validation).
* Authoring project validation master plans, SOP and documentation updates, and validation protocols and final reports.
* Executing validation studies, analysing validation data, and resolving technical issues encountered during study execution.
Requirements:
* Minimum 6 years C&Q/QA/QC/Validation experience in a highly regulated industry
* Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project, or new facility introduction
* SME on Equipment Qualification on any: Cleaning & Parts Washers for in-process components/Vaporised Hydrogen Peroxide Isolators/Clean Utilities & Transfer Panels/Vial & Syringe Filling & Inspection.