CQV Engineer

CAI; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

CAI is seeking an experienced CQV Engineer to join a dynamic project team delivering complex pharmaceutical or life sciences projects in Ireland.

Responsibilities include executing CQV activities, supporting commissioning and qualification of equipment, and managing validation documents. You will coordinate with multidisciplinary teams to deliver on time while ensuring safety and regulatory compliance.

Qualifications

• Experience in 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 with equipment, process systems, clean utilities, facilities or automation systems.
• Strong documentation, problem-solving and stakeholder engagement skills.

Responsibilities

• Execute 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?

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

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.