Diegem CQV Engineer Life Sciences

Job description

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 most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide 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 are the 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