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Lead CQV CIP Engineer

  1. East Coast
North Carolina
  1. Permanent
Competitive
  1. Commissioning, Qualification and Validation
21-05-2024
33948
Lead CQV CIP Engineer - Pharmaceuticals - Raleigh, NC - 12-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented Lead CQV CIP 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.


Responsibilities:
  • CQV Lead Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from the A/E firm including Drawings, Datasheets, specifications and Engineering Lists.
  • Lead generation of all CQV CIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Point CQV person for Vendor review for all CIP Vendor Packages.
  • CQV SME for all CIP Systems. Produce CIP Bridging to include all CCP, CQAs and worst case information of circuits.
  • Lead all circuit reviews for all CIP routes and circuits, working out “worst case” scenarios for testing and cleaning requirements.
  • Liaise with construction manager in relation to construction readiness and a schedule for all CIP 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 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 CIP Systems, ensuring all correct predecessors and successors are in place.

Requirements:
  • Minimum 10 years Equipment experience on Large Scale Biopharmaceutical Projects
  • SME on all CIP Systems, minimum 5 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads


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

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