CQV CIP engineer

CQV CIP engineer Holly Springs, NC Description: Need an entry to mid-level CQV CIP engineer with an intermediate level of understanding of Validation and Quality Assurance. 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 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. Experience: SME on all CIP Systems, minimum 3-5 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 Can-Do attitude) and strong collaboration. Acts with detail-driven ownership and follow through.

Created: 2026-03-04