CQV Engineer

About the Company

Our client is a global biotechnology leader dedicated to developing innovative therapies that improve the lives of patients worldwide. Operating within a highly regulated GMP environment, the company combines scientific excellence, advanced manufacturing technologies, and a strong commitment to quality to deliver life-changing medicines. With a collaborative culture and a focus on continuous improvement, this is an exciting opportunity to contribute to projects that have a direct impact on patients around the globe.

About the Role

As a Commissioning Qualification & Validation (CQV) Engineer, you will play a key role in supporting engineering and technical projects across a GMP manufacturing environment. Reporting to the Senior Manager Validation & Compliance, you will be responsible for the commissioning, qualification, and validation of systems and equipment, ensuring technical solutions meet regulatory requirements, company standards, and customer expectations.

This role offers the opportunity to work on complex pharmaceutical manufacturing projects while collaborating closely with engineering, operations, quality, and project teams.

Responsibilities

• Develop, review, and maintain validation lifecycle documentation, including:
• System Criticality Assessments
• Commissioning, Qualification & Validation Plans
• Risk Assessments
• Test Protocols
• Requirements Traceability Matrices
• CQV Summary Reports
• Lead commissioning, qualification, and validation activities for GMP systems and equipment.
• Execute validation strategies in line with regulatory standards and site procedures.
• Support technical project teams by ensuring validation requirements are incorporated throughout project execution.
• Provide subject matter expertise on CQV activities within secondary packaging operations.
• Ensure technical solutions are implemented in accordance with approved validation plans and GMP requirements.
• Collaborate with cross-functional stakeholders to drive successful project delivery.
• Support compliance initiatives and continuous improvement activities within the engineering organisation.
• Perform additional project-related activities as required.

Requirements

• Bachelor's degree or equivalent qualification in Engineering, Life Sciences, Biotechnology, or a related discipline.
• Minimum 3 years of experience in Commissioning, Qualification and Validation within the pharmaceutical or biotechnology industry.
• Hands-on experience with Secondary Packaging Systems.
• Experience with Print & Inspection Systems, such as Systech and Cognex.
• Strong knowledge of GMP-regulated manufacturing environments.
• Experience developing and executing CQV documentation and testing activities.
• Excellent technical writing and documentation skills.
• Fluent in English, both written and spoken.

What You'll Get in Return

• 12 month contract via Hays.
• Competitive salary starting from €59,400 gross per year , with further flexibility depending on experience and qualifications.
• Opportunity to join a globally recognised biotechnology organisation.
• Exposure to large-scale GMP manufacturing and capital projects.
• Collaborative and innovative working environment.
• The chance to contribute to projects that directly impact patient lives worldwide.

What You Need to Do Now

If you're interested in this opportunity, click 'Apply Now' to submit your application. If this role isn't quite right for you but you're looking for a new position within Life Sciences, Engineering, Validation or Quality, please contact us for a confidential discussion about your career.