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CQV Clean Utilities Engineer

  1. United States
  1. Contract
Competitive
  1. Compliance / Quality Assurance
12-02-2024
32884
CQV Clean Utilities Engineer - Raleigh NC, USA - 12-Month Contract

Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV Clean Utilities 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.


Main Responsibilities;

  • CQV Support Engineer for Clean Utilities, initially responsible for issue and review of all FAT wraparounds, DQ, RTM and QRA activities, then IOC/SAT and IOQ, including SR’s. Also review of all Design deliverables including Drawings, Datasheets, specifications and Engineering Lists.
  • Aligning system boundaries and Support and review exercise.
  • Point CQV person for Vendor review for all Clean Utility Vendor Packages.
  • CQV SME for all Clean Utility Systems.
  • Support CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages.
  • Support CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase.
  • Liaise with CQV PM and Support Scheduler in relation to schedule creation and management for all Clean Utility Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Clean Utility Systems to support Equipment Start-up and IOQ Testing.
  • Support PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.

Knowledge and Skill;
  • Minimum of 10 years of Clean Utility experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 5 years experience in Supporting Clean Utility 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.
  • 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)
  • Minimum 10 years CQV Clean Utility experience on Large Scale Projects
  • SME on both Clean and Black Clean Utility Systems, minimum 10 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process

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