CQV Engineer | Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Capgemini Engineering in Belgium is seeking a CQV Engineer to ensure quality, compliance and validation of critical systems and processes within the Life Sciences sector. You will support validation activities across projects from new facilities to upgrades.

You will develop IQ/OQ/PQ protocols, lead commissioning, review technical docs, and collaborate with engineering, quality assurance and operations to ensure audit-ready records and timely delivery.

Qualifications

• Minimum 2 years in commissioning, qualification, and/or validation in Life Sciences (pharma/biotech/medical devices).
• Strong GMP knowledge: FDA 21 CFR, EU GMP Annex 15, GAMP 5.
• Excellent communication and collaboration across cross-functional teams.
• Engineering or Life Sciences degree with proactive problem-solving mindset.
• Proficiency in French and/or Dutch and English.

Responsabilités

• Developing and executing validation protocols (IQ, OQ, PQ) for equipment, utilities, and manufacturing systems.
• Leading and supporting commissioning, qualification, and validation activities across projects, ensuring timely and compliant delivery.
• Collaborating with engineering, quality assurance, and operations to align validation with project timelines and client expectations.
• Preparing and reviewing validation master plans, risk assessments, deviation reports, and summary reports for regulatory compliance.

Connaissances

CQV/Commissioning

Validation

GMP knowledge

Regulatory compliance

Multilingual

Formation

Engineering degree

Life Sciences degree

Description du poste

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same.

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.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.