CQV Engineer

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

Are you an experienced CQV Engineer looking to join a dynamic project team delivering complex pharmaceutical or life sciences projects? We are seeking a driven and collaborative CQV professional to support commissioning, qualification and validation activities across a range of GMP regulated systems, facilities and equipment. This is an excellent opportunity to work on high impact projects in a fast paced and technically challenging environment.

Key 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

What We're Looking For

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.

Why Apply?

Opportunity to work on industry-leading projects Exposure to cutting-edge manufacturing technologies Collaborative and supportive team environment Competitive salary or contract rates available Potential for long-term career progression

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