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CQV CIP Engineer

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
32218

This vacancy has now expired

CQV CIP Engineer - Pharmaceuticals - North Carolina - 15-Month Contract 

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

Main Responsibilities;
  • CQV Lead Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from engineering 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.
  • Ensure Commissioning readiness of all CIP Systems to support Equipment Start-up and IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Lead CQV CIP Systems 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
  • CIP Systems are managed appropriately for the entire Project Lifecycle.
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design
  • Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
  • Lead execution of all CIP systems and CQV deliverables; FAT/SAT/IOQ
  • Run Weekly CQV CIP Meeting and ensure updates are provided to Weekly CQV Meeting.
  • Generate and ensure timely approval of all SAT and IOQ Final Reports.

Experience and contacts;
  • 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
 
Knowledge and Skill;
  • Minimum of 10years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 5years 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)
  • Candidate must be flexible to travel for acceptance tests, OEM site visits, etc.

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

The candidate must have the rights to work in the location stated in the job advert.

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