Key Skills
Job Description
CAI is seeking experienced Commissioning, Qualification & Validation (CQV) Engineers to support a large scale pharmaceutical manufacturing project. 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 Requiremenst
• 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.
\nCore Responsibilities
The CQV Engineer will execute commissioning, qualification, and validation activities for process, utility, and facility systems in a GMP environment. They will also collaborate with multidisciplinary teams to ensure project delivery, system startup, and regulatory compliance.
Requirements
Candidates must have previous CQV experience within pharmaceutical, biotech, or life sciences manufacturing environments. A strong understanding of commissioning methodologies and GMP documentation is required, along with the legal right to work in the EU.
About CAI
Industry: Pharmaceutical Manufacturing
Company size: 501-1,000 employees
At CAI, we are a professional services firm designed to accelerate operational readiness and excellence in critical environments. Our team of engineering, quality, and operations experts combines top-tier talent with the latest technology to deliver projects on time and within budget. We're committed to continuous improvement, real connections, and the highest standards, aiming to lead the industry and build the future. Are you ready?
