Entry to Mid-level CQV CIP engineer

Roles & Responsibilities:

• CQV Lead 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.
• 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 preM/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 Startup and IOQ Testing.
• Lead PSSR/STW field execution and guide CQV Team through Startup 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.

Experience:

• SME on all CIP Systems minimum 35 years
• Working knowledge of ASTM E2500 / Leveraging Verification process
• Experience with liaising with other departments and building PMs/leads
• Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
• Experience with liaising with other departments and engineers/QA ensuring streamlined implementation of documentation review process or similar type process.
• Willingness to step in a proactive manner for driving progress.
• Strong communication skills and ability to escalate issues as needed.
• BA/BS in a related field and 3 years experience successfully executing complex projects in a Pharma/cGMP environment.
• Emphasis for this hire is on attitude (Positive CanDo attitude) and strong collaboration.
• Acts with detaildriven ownership and follow through.