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CQV Lead - Clean Utilities

  1. Dublin
  1. Contract
Competitive
23414 / AE
  1. Commisions, Qualification and Validation
Date Posted06 Sep 2019
CQV Lead required to join a global biotech company located in the north of Ireland. The CQV lead will specifically be responsible for clean utilities implementation onto a greenfield biotech site.


Role: 
  • Liaise with suppliers in relation to construction readiness and a schedule for all Clean Utilities systems, perform and lead all field walk-downs for all systems.
  • Assist CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Clean Utilities scope. 
  • Liaise with CQV SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase for all Clean Utilities systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Clean Utilities Systems to support Equipment Start-up and CQV Testing.
  • Assist PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Assist CQV Clean Utilities’ with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Clean Utilities Systems are managed appropriately for the entire Project Lifecycle.
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; Design Reviews/SLIA/Test Matrices/FAT/SAT/CTP Protocols.
  • Support execution of all Clean Utilities CQV deliverables; FAT/SAT/CTP.
  • Assist with Weekly CQV Clean Utilities Meeting and ensure updates are provided to Weekly CQV Meeting.

Requirements: 
  • Minimum of 8 years of Clean Utilities experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Minimum 8 years’ experience in Leading Clean Utilities 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)


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