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CQV Downstream Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37148
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CQV Downstream Engineer - US, North Carolina - 6-12 Months Contract 

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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Senior CQV Engineer for Equipment in the Downstream Area for the DSM Building, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications, and Engineering Lists.
  • Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Downstream 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 Downstream Vendor Packages. CQV SME for all Downstream Systems.
  • Liaise with Jacobs in relation to construction readiness and a schedule for all Downstream systems, perform and lead all field walkdowns for all systems.
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages.
 Requirements:
  • Extensive CQV Downstream Equipment experience on Large Scale Projects.
  • Strong SME experience on all Downstream Systems.
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads
  • Extensive equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Experience in Leading Equipment CQV Team
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
If you are interested, please apply now for immediate consideration and further information.
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