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CQV Downstream Engineer

  1. East Coast
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
19-09-2023
32013
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CQV Downstream Engineer - North Carolina - 12 months

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Downstream 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 DST Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports
  • Generate DST 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 DST Vendor Packages. CQV SME for all DST Systems
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope
  • Ensure Commissioning readiness of all DST Systems to support Equipment Start-up and IOQ Testing
  • Support PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner
  • Support CQV DST Systems with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems
  • Support execution of all DST systems and CQV deliverables; FAT/SAT/IOQ
  • Support Weekly CQV DST Meeting and ensure updates are provided to Weekly CQV Meeting
  • Generate and ensure timely approval of all SAT and IOQ Final Reports
Requirements
  • Minimum 3 years CQV DST Equipment experience on Large Scale Projects
  • SME on all DST Systems, minimum 3 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads
  • Minimum of 3 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities
  • Minimum 3 years experience in Leading Equipment CQV Team
  • Experience with complex projects and working in or around operating facilities
  • Computer skills (Paperless Validation Software, Spreadsheets, Word Processing, Visio, Microsoft Project)
If this job is of interest to you, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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