Commissioning and Qualification Lead

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

Job summary

NIRAS is seeking a Commissioning & Qualification Lead for a long-term contract on a large scale Capital Engineering Project in Puerto Rico. The role involves supporting the Commissioning & Qualification Manager in planning and executing C&Q activities for Process Equipment, Utilities, Facilities, and related systems.

The ideal candidate will have 10 years’ experience in CQV, strong leadership skills, and a solid GMP background, with proficiency in English and Spanish.

Qualifications

• 10 years’ experience in commissioning, qualification, validation, engineering.
• Deep field experience leading/coordinating CQV activities on large scale life science projects.
• Familiarity with GMP requirements and risk-based C&Q principles.

Responsibilities

• Lead and coordinate C&Q activities for systems and project areas.
• Develop and maintain C&Q schedules, plans, resources, and deliverables.
• Ensure all C&Q activities meet GMP, FDA, and project requirements.

Skills

CQV Leadership

Project Coordination

GMP Compliance

English/Spanish Proficiency

Education

Engineering degree or higher

Job description

Who We are:

One of Europe's largest development consulting firms NIRAS 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 NIRAS 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