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CQV Upstream Engineer – Commissioning

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36813
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CQV Upstream Engineer, Commissioning - North Carolina, United States - 12 Months Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Upstream Engineer – Commissioning 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 Upstream Area for the DSM Building, initially responsible for review of all Design deliverables including Drawings, Datasheets, specifications and Engineering Lists.
  • 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.
  • 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. Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems.
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream Systems, ensuring all correct predecessors and successors are in place.
  • 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.
Requirements:
  • Extensive CQV experience
  • Can work independently
  • Ability to travel for FAT’s
  • Experience with liaising with other departments and building PMs/leads
  • Extensive equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Extensive 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.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
If you are interested, please apply now for immediate consideration and further information.
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