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CQV CIP Engineer

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
34360
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CQV CIP Engineer - North Carolina - 12-Month Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV CIP Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.


Responsibilities: 
  • CQV Support Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
  • Support 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.
  • Support 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 Support all field walkdowns for all systems.
  • Support 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 Support Scheduler in relation to schedule creation and management for all CIP Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all CIP Systems to support Equipment Start-up and IOQ Testing.


Requirements: 
  • Extensive 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
  • Minimum of 10 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 5 years experience on Equipment 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)

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

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