Validation Engineer

Clean Utilities / Validation Engineer

Our client, a global pharmaceutical manufacturing organization are looking for a talented Validation 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 from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
• Aligning with Jacobs on 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.
• Liaise with Jacobs in relation to construction readiness and a schedule for all Clean Utility systems, perform and Support all field walk downs 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.
  
  

Experience and contacts;

• 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
• Clean Utility experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
• Extensive 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.
  
  

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