Summary: The Validation Engineer role involves supporting Clean Utilities within a global pharmaceutical manufacturing organization, focusing on the validation processes for a new manufacturing facility on the East Coast of the United States. The position requires extensive experience in Clean Utility systems and collaboration with various stakeholders, including Jacobs and vendors, to ensure compliance and readiness for construction and operational phases. This is a critical role in a rapidly growing organization, offering the opportunity to contribute significantly to large-scale projects.

Key Responsibilities:

• CQV Support Engineer for Clean Utilities, responsible for issue and review of all FAT wraparounds, DQ, RTM and QRA activities, IOC/SAT and IOQ, including SR’s, and review of all Design deliverables from Jacobs.
• 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 regarding construction readiness and schedule for all Clean Utility systems, performing and supporting all field walk downs.
• Support CQV review, aligning with Transition Group for review and approval of all Turnover Packages.
• Support CQV SWAT Team in relation to punchlist closure both pre-M/C and during CQV execution phase.
• Liaise with CQV PM and Support Scheduler for schedule creation and management for all Clean Utility Systems.

Key Skills:

• 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 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 in communicating and collaborating with customers, vendors, equipment suppliers, and operations staff.

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other