CQV Engineer — GMP Validation & Commissioning Lead

Commissioning Agents Inc (CAI); Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Commissioning Agents Inc (CAI) is seeking an experienced CQV Engineer to join a dynamic project team delivering complex pharmaceutical and life sciences projects. The role supports commissioning, qualification and validation activities across GMP systems, facilities and equipment in a fast-paced environment.

You will work on construction-ready CQV activities, contribute to design reviews and ensure documentation and compliance standards are met.

Qualifications

• Experience within Pharmaceutical, Biotechnology, Medical Device or Life Sciences industries.
• Background in Commissioning, Qualification, Validation, Engineering or Technical Operations.
• Understanding of GMP and regulated manufacturing environments.
• Experience working with equipment, process systems, clean utilities, facilities or automation systems.
• Strong documentation, problem-solving and stakeholder engagement skills.
• Ability to work effectively as part of a multidisciplinary project team.

Responsibilities

• Execute Commissioning, Qualification and Validation (CQV) activities in line with project schedules and GMP requirements.
• Support commissioning, startup and qualification of equipment, utilities and process systems.
• Prepare, review and execute validation documentation including protocols, reports, and traceability matrices.
• Lead or participate in design reviews, FATs, SATs, commissioning, IQ, OQ and PQ activities.
• Manage qualification documentation through the full CQV lifecycle.
• Coordinate activities with engineering, operations, quality, contractors and equipment vendors.
• Track progress, identify risks and support timely project delivery.
• Assist with change controls, deviations, punch lists and documentation management.
• Ensure all activities are performed to the highest safety and compliance standards.
• Provide technical support during project execution and system handover.

Job description

Commissioning Agents Inc (CAI) is seeking an experienced CQV Engineer to join a dynamic project team delivering complex pharmaceutical and life sciences projects. The role supports commissioning, qualification and validation activities across GMP systems, facilities and equipment in a fast-paced environment.

You will work on construction-ready CQV activities, contribute to design reviews and ensure documentation and compliance standards are met.