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CQV Engineer

  1. Ireland, Midlands (Ireland)
Carlow
  1. Contract
Competitive
  1. CAPEX Projects
36077
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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:
  • 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.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.

Requirements:
  • Minimum 6 years C&Q/ QA/ QC/ Validation experience in 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

If this role is of interest to you, please apply now! 


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