CQV Project Manager

Position Overview

The Commissioning / CQV Project Manager will lead the end‑to‑end commissioning of an R&D laboratory retrofit at a major pharmaceutical site in Rahway, NJ. The primary focus of this role is planning, coordinating, and executing commissioning activities for all building utilities, MEP systems, and laboratory equipment to ensure the lab is fully functional, safe, and ready for turnover to operations. Qualification/validation oversight is included but secondary to commissioning management.

Key Responsibilities

Commissioning Leadership & Execution

• Lead the complete commissioning life cycle for the R&D lab retrofit, from early planning through system handover.
• Develop and manage the Commissioning Plan, commissioning strategy, and system-level commissioning scopes.
• Define commissioning boundaries, system turnover packages, and system readiness criteria (construction complete, pre‑functional, functional).
• Plan, coordinate, and execute:
• Pre‑functional checks (installation verification, static checks, walkdowns).
• Functional performance testing of utilities, building systems, and lab equipment.
• Integration testing across interfaces (e.g., utilities to equipment, BMS/EMS to field devices).
• Ensure proper documentation of all commissioning activities, test results, field changes, and deficiencies.

Systems & Equipment Commissioning

• Oversee commissioning of:
• Mechanical, electrical, and plumbing systems (MEP).
• Lab and process utilities (e.g., HVAC/cleanroom environments, exhaust systems, chilled water, steam, compressed air, process gases, purified water, vacuum).
• Lab equipment and instruments (e.g., fume hoods, biosafety cabinets, incubators, refrigerators/freezers, analytical instruments, chromatography systems, environmental chambers, washers/autoclaves as applicable).
• Building automation systems (BMS), environmental monitoring systems (EMS), and relevant control systems.
• Confirm equipment installation, utility connections, controls integration, and safe operation per manufacturer requirements and project design.

Coordination with Construction, Vendors & Stakeholders

• Serve as the primary commissioning point of contact for the client, EPCM/construction team, and equipment vendors.
• Integrate vendor FAT/SAT activities into the overall commissioning plan; ensure vendor testing is aligned with site requirements.
• Coordinate field activities with construction to manage system turnover, access, and sequencing of commissioning activities.
• Collaborate closely with Facilities, Engineering, QA, EHS, and R&D end‑users to align on system requirements, acceptance criteria, and operational needs.

Documentation & CQV Integration

• Oversee creation and execution of commissioning forms, checklists, test scripts, issue logs, and commissioning reports.
• Ensure proper traceability from design requirements and URS to commissioning tests.
• Coordinate with CQV/Validation teams so that commissioning outputs feed efficiently into IQ/OQ/PQ (where required).
• Support and, when needed, review CQV protocols and reports to ensure they are consistent with commissioning outcomes and field realities.

Quality, EHS & Compliance

• Ensure commissioning activities adhere to site quality standards, GxP expectations (where GxP impact exists), and EHS policies.
• Drive resolution of commissioning issues, punch list items, deviations, and non‑conformances.
• Promote safe commissioning practices, including LOTO, energization procedures, and start‑up risk assessments.

Planning, Controls & Reporting

• Develop and maintain a detailed commissioning schedule, integrated with overall project milestones.
• Forecast resource needs (internal, vendor, and contractor) and coordinate mobilization of commissioning resources.
• Track progress against plan, manage risks and constraints, and implement mitigation strategies.
• Provide regular commissioning status reports, metrics, and readiness assessments to client leadership.

Qualifications

Required

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related) or equivalent technical discipline.
• 7 years of experience in commissioning and/or CQV within pharmaceutical, biotech, or similar regulated facilities.
• Strong hands‑on experience commissioning utilities, MEP systems, and laboratory equipment, preferably in an R&D or lab setting.
• Demonstrated experience leading commissioning on retrofit or brownfield projects (active or partially active facilities).
• Familiarity with relevant industry guidelines and best practices for commissioning (e.g., ASHRAE, ISPE, ASTM E2500, GAMP concepts).
• Proven ability to manage schedules, priorities, and multidisciplinary teams in a construction/retrofit environment.
• Excellent field coordination, problem‑solving, and communication skills.
• Ability to work full‑time, onsite in Rahway, NJ.