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CQV Downstream Engineer

  1. United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
35692
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CQV Downstream Engineer - Pharmaceuticals - 12-Month Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV IV Engineer to join their expanding team. They are making an investment of more than $2 Billion USD to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business. 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.


Responsibilities:
  • 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, both Vendor and Contractor Packages within the Process Equipment Support scope.
  • Liaise with CQV SWAT Team in relation to punch list 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
  • Downstream Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Downstream 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.

Knowledge and Skill;
  • 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.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

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

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