CQV Engineer

CAI; Dublin; On-site; EUR 85,000 - 95,000; Full time

Job summary

CAI is seeking experienced Commissioning, Qualification & Validation (CQV) Engineers to support a large scale pharmaceutical manufacturing project in the Netherlands. This role offers the opportunity to work within a multidisciplinary team delivering critical process, utility, and facility qualification activities in a GMP regulated environment.

This is a site-based role with eligibility to work in the EU without visa sponsorship, now or in the future.

Qualifications

• Previous CQV experience within pharmaceutical, biotech, or life sciences manufacturing environments.
• Strong understanding of commissioning and qualification methodologies.
• Experience supporting regulated manufacturing facilities and associated utility systems.
• Exposure to complex process equipment and containment-focused manufacturing operations is highly desirable.
• Familiarity with GMP documentation, protocol execution, and project lifecycle delivery.

Responsibilities

• Execute commissioning and qualification activities for process, utility, and facility systems.
• Develop, review, and execute qualification documentation in line with project and regulatory requirements.
• Support system turnover, startup, and operational readiness activities.
• Liaise with engineering, quality, operations, and project stakeholders to ensure successful project delivery.
• Participate in walkdowns, punch-list resolution, and troubleshooting activities.
• Ensure compliance with site quality, safety, and GMP procedures.

Job description

CAI is seeking experienced Commissioning, Qualification & Validation (CQV) Engineers to support a large scale pharmaceutical manufacturing project in the Netherlands. This role offers the opportunity to work within a multidisciplinary team delivering critical process, utility, and facility qualification activities in a GMP regulated environment.

Responsibilities

• Execute commissioning and qualification activities for process, utility, and facility systems.
• Develop, review, and execute qualification documentation in line with project and regulatory requirements.
• Support system turnover, startup, and operational readiness activities.
• Liaise with engineering, quality, operations, and project stakeholders to ensure successful project delivery.
• Participate in walkdowns, punch-list resolution, and troubleshooting activities.
• Ensure compliance with site quality, safety, and GMP procedures.

Experience Required

• Previous CQV experience within pharmaceutical, biotech, or life sciences manufacturing environments.
• Strong understanding of commissioning and qualification methodologies.
• Experience supporting regulated manufacturing facilities and associated utility systems.
• Exposure to complex process equipment and containment-focused manufacturing operations is highly desirable.
• Familiarity with GMP documentation, protocol execution, and project lifecycle delivery.

Preferred Experience

Candidates with experience in one or more of the following areas are particularly encouraged to apply:

• High containment or high potency manufacturing environments
• Process equipment qualification
• Manufacturing support systems and clean utilities
• HVAC and facility qualification
• Packaging, processing, or solid dosage manufacturing operations
• Safety critical or hazardous processing environments

Other Requirements

This is a site-based role

Eligible to work in the EU without the need for visa sponsorship, now or in the future.

Why CAI?

At CAI, our people are at the heart of everything we do. We partner with the world's leading life sciences companies to deliver innovative projects that ultimately improve patient lives. You'll work alongside industry leading experts in a collaborative environment that supports professional growth and technical excellence.

If you're a CQV professional looking to contribute to a challenging pharmaceutical project while developing your career with a global consultancy, we'd love to hear from you.

€85,000 - €95,000 a year