CQV Lead for Large-Scale Pharma Capital Projects

Clear.; Barceloneta (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

NIRAS is seeking a Commissioning & Qualification Lead for a long-term, on-site role at a state‑of‑the‑art biologics facility in Puerto Rico. You will support the CQ Manager in planning and executing C&Q activities for process equipment, utilities, facilities and related systems.

The role requires leading CQV activities, coordinating engineers, SMEs, contractors and vendors, ensuring GMP compliance, risk‑based approaches, and readiness for audits, FAT/SAT, and system turnover.

Qualifications

• 10 years’ experience in commissioning, qualification, validation, engineering.
• In depth field experience leading/coordinating CQV activities on large-scale life science capital projects.
• Degree qualification or higher in engineering, science, life sciences, or related discipline.
• Preferred: experience in biotechnology/pharma/med device sectors.
• Experience across facilities, clean utilities, process utilities, HVAC, water, or lab systems.

Responsibilities

• Develop and maintain CQV schedules, plans, resources, and deliverables.
• Coordinate CQV engineers, SMEs, contractors, and equipment vendors.
• Lead and coordinate CQV activities for systems and project areas.
• Ensure CQ activities are in the integrated project schedule and meet milestones.
• Prepare, review, and execute commissioning tests, protocols, and turnover docs.
• Apply risk-based CQ principles to assigned systems.
• Review CQ documentation for completeness, accuracy, traceability, and GMP compliance.
• Support deviations, non-conformances, test failures, and punch-list items.
• Provide regular updates on CQ progress, risks, and schedule performance.
• Support FAT/SATs, system turnover, operational readiness, and project handover.
• Assist audits, inspections, and readiness reviews; ensure health, safety, quality, GMP compliance.

Skills

CQV leadership

Life science projects

Documentation skills

Communication skills

Engineering background

Education

Engineering degree or higher

Tools

Lab/Manufacturing Automation systems

Building Management Systems

Manufacturing Execution Systems

Job description

NIRAS is seeking a Commissioning & Qualification Lead for a long-term, on-site role at a state‑of‑the‑art biologics facility in Puerto Rico. You will support the CQ Manager in planning and executing C&Q activities for process equipment, utilities, facilities and related systems.

The role requires leading CQV activities, coordinating engineers, SMEs, contractors and vendors, ensuring GMP compliance, risk‑based approaches, and readiness for audits, FAT/SAT, and system turnover.