CQV Engineer - Life Sciences

YOUR ROLE

As a CQV Engineer, you will play a key role in ensuring the quality, compliance, and validation of critical systems and processes within the Life Sciences industry. In this role you will play a key role in:

• Developing and executing validation protocols (IQ, OQ, PQ) for equipment, utilities, and manufacturing systems in accordance with GMP guidelines and regulatory requirements.
• Leading and supporting commissioning, qualification, and validation (CQV) activities across a range of projects, from new facility builds to equipment upgrades, ensuring timely and compliant delivery.
• Collaborating with cross-functional teams including engineering, quality assurance, and operations to ensure validation activities are aligned with project timelines and client expectations.
• Preparing and reviewing technical documentation such as validation master plans, risk assessments, deviation reports, and summary reports to ensure full regulatory compliance.
• Supporting regulatory inspections and audits by providing technical expertise and ensuring all CQV documentation is audit-ready and meets the standards of bodies such as the FDA, EMA, and FAMHP.

YOUR PROFILE

We are looking for a motivated and detail-oriented professional who thrives in a regulated environment. You will bring:

• A minimum of 2 years of experience in commissioning, qualification, and/or validation within the Life Sciences industry, including pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of GMP regulations and guidelines such as FDA 21 CFR, EU GMP Annex 15, and GAMP 5, with a proven ability to apply these in a practical, project-based environment.
• Excellent communication and collaboration skills, with the ability to work effectively within multidisciplinary teams and engage confidently with clients and stakeholders at all levels.
• A degree in Engineering, Life Sciences, or a related field, combined with a proactive, problem-solving mindset and strong attention to detail.
• Proficiency in both French and/or Dutch, as well as English, enabling effective communication in Brussels' multilingual professional environment.

What you will love about working here

• Empowering environment - Autonomy and Goal setting are among the top scores with 8,4+ ratings in our monthly employee feedback Pulse.
• FlexAbroad - Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.
• Free access to learning platforms - Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.
• Worldwide Leader of Engineering Services - Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. We help our clients unleashing their R&D potential to develop smart products and services of tomorrow.