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CQV Upstream Engineer

  1. East Coast
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
15-09-2023
32012
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CQV Upstream Engineer – North Carolina – 12 months

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Upstream Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Main Responsibilities
  • Support generation of all CQV Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Upstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • Point CQV person for Vendor review for all Upstream Vendor Packages. CQV SME for all Upstream Systems.
  • Ensure Commissioning readiness of all Upstream Systems to support Equipment Start-up and IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Lead CQV Upstream Systems with EIDA, always ensure full traceability for all systems.
  • Lead execution of all Upstream systems and CQV deliverables; FAT/SAT/IOQ
  • Run Weekly CQV Upstream Meeting and ensure updates are provided to Weekly CQV Meeting.
Requirements
  • Minimum 5 years CQV Upstream Equipment experience on Large Scale Projects
  • SME on all Upstream Systems, minimum 5 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads.
  • Minimum of 5 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 5 years’ experience in Leading Equipment CQV Team
  • Experience with complex projects and working in or around operating facilities.
If this job is of interest to you, please apply now!



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