Commissioning and Qualification Lead

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

Who We are:

One of Europe's largest development consulting firm our client employs over 3000 permanent staff and over 25,000 experts across our Global network. With 4 offices in Ireland and 51 offices in 32 countries, NIRAS specializes in the design and delivery of process-driven projects, providing Project Management, Engineering Design, Project and Managed Service resources to the Life Science, Food & Beverage and Advanced Process Manufacturing industries across Ireland and internationally.

An exciting new long term contract opportunity has arisen to work with the client on a large scale Capital Engineering Project onsite at our clients advanced Biologics facility in Puerto Rico. On this project, the Commissioning & Qualification Lead will support our client’s Commissioning & Qualification Manager in planning and executing C&Q activities for Process Equipment, Utilities, Facilities, and related systems.

The C&Q Lead will provide day-to-day technical leadership and coordination for C&Q activities, ensuring systems are commissioned and qualified safely, on schedule and in accordance with project requirements, company procedures, GMP expectations, and relevant industry standards. This position may also support Aseptic Fill‑Finish, Bulk Drug Substance, or other pharmaceutical manufacturing projects.

Responsibilities:

• Support the C&Q Manager in developing and maintaining C&Q schedules, plans, resource requirements, and deliverables.
• Coordinate C&Q Engineers, Subject Matter Experts, Contractors, and Equipment Vendors.
• Lead and Coordinate all C&Q activities for systems and project areas.
• Coordinate with Engineering, Construction, Quality, Operations, Maintenance, Automation, Project Controls, and external Vendors Ensure C&Q activities are incorporated into the integrated project schedule, and delivered in line with project milestones.
• Coordinate preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Apply risk‑based commissioning and qualification principles to assigned systems.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support investigation and resolution of deviations, non‑conformances, test failures, punch‑list items, and other C&Q issues.
• Provide regular and timely updates on C&Q progress, risks, issues, and schedule performance.
• Support FAT/SATs, System Turnover, Operational Readiness, and Project Handover activities.
• Support Audits, Inspections, and Project Readiness Reviews.
• Ensure all activities are performed in accordance with applicable Health, Safety, Environmental, Quality, and GMP requirements.

Requirements:

• 10 years’ experience in commissioning, qualification, validation, engineering.
• In depth field experience leading/coordinating CQV activities on critical, large scale, life science, capital projects.
• Degree qualification or higher in engineering, science, life sciences, or a related engineering discipline.
• Preferred candidates will have ideally worked within biotechnology, pharmaceutical, med device industries.
• Experience across the following areas Facilities, Clean Utilities, Process Utilities, HVAC, Process Equipment, Water, Manufacturing or Lab Systems.
• Strong working knowledge of GMP requirements and risk‑based C&Q principles.
• Familiarity with FDA expectations, ICH Q8/Q9/Q10, ISPE guidance, Annex 1, ISO Standards and relevant industry standards.
• Experienced in supporting deviations, change controls, non‑conformances, and corrective actions.
• Will have strong organizational, communication and problem‑solving skills.
• Experienced in developing, reviewing, and executing C&Q documentation and protocols.
• Experienced in collaborating with specialist equipment vendors, engineering contractors, site operations and construction teams
• Highly adaptive and capable of managing multiple priorities, whilst working effectively in fast‑paced project environments.

Preferred Candidate Profile/ Expertise

• Experienced contractor, comfortable working within fast paced large-scale pharmaceutical capital project environments.
• Expertise across two or more of the following areas Cleanrooms, HVAC, Process Gases, Purified Water, WFI, Clean Steam, or other Critical Utilities.
• Experienced working in Biologics, Sterile Manufacturing Environments, Aseptic Fill‑Finish, Bulk Drug Substance Manufacturing Projects.
• Familiarity and practical working experience of Process Automation and Computerized Systems including Lab/Manufacturing Automation systems, , Building Management Systems, or Manufacturing Execution Systems.
• Expertise providing support across FATs/SATs, System Turnover, and Operational Readiness.
• Proficiency in written and spoken English and Spanish.