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CQV Lead

  1. East Coast
  1. Contract
Competitive
26365
  1. CAPEX Projects
Date Posted08 Apr 2021
CQV Lead Drug Substance Upstream & Downstream - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a CQV Lead to work on the multi-billion-dollar project.

The Role:
  • CQV Lead Engineer for all Upstream & Downstream systems (Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification-etc), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
  • Review of all Design deliverables from EPCM, including Drawings, Datasheets, specifications and Engineering Lists. Also assist in GMP reviews. Author all CQV sub plans (VPP) for Upstream/Downstream Areas. Review of all GMP generated documentation via the KNEAT system.
  • Liaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS system.
  • Aligning with EPCM and CQV Turnover Lead in relation to System boundaries and Lead and review exercise.
  • Point CQV person for Vendor review for all Upstream/Downstream Vendor Packages.
  • CQV SME for all Upstream/Downstream Systems.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Upstream/Downstream   systems.  Lead CQV effort for schedule review and readiness.  Also perform and lead all field walk-downs for all Upstream/Downstream 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 Upstream/Downstream Areas. 
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Upstream/Downstream Systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream/Downstream Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Upstream/Downstream Systems to support Equipment Start-up and IOC-IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Upstream/Downstream Systems are managed appropriately for the entire Project Lifecycle.
  • Lead execution of all Upstream/Downstream CQV deliverables; FAT/SAT/CTP/IOQ.
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
 
If this role interests you, apply today.

 



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