- Fill Finish - Pharmaceuticals - Carlow - 12-Month Contract
With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a CQV Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary
1. Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilisation validation), authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data, and resolving technical issues encountered during study execution.
2. Technical review and approval of Commissioning protocols, Qualification protocols, and Validation protocols executed by vendors, cross-functional groups, and/or validation counterparts.
3. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
Requirements
1. Minimum 6 years C&Q/ QA/ QC/ Validation experience in a highly regulated industry.
2. Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project, or new facility introduction.
3. 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.
If this role is of interest to you, please apply now! #J-18808-Ljbffr