CQV Engineer- 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; 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
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