CSV Engineer | Life Sciences

Your Role

As a CSV Engineer, you will play a key role in ensuring the validation and compliance of computerised systems used within the Life Sciences industry. In this role you will play a key role in:

• Developing and executing Computer System Validation (CSV) protocols in accordance with GAMP 5, 21 CFR Part 11, EU Annex 11, and other relevant regulatory frameworks, ensuring full compliance throughout the system lifecycle.
• Leading and supporting validation activities for a wide range of computerised systems including MES, LIMS, ERP, and process control systems, from user requirements through to final validation reporting.
• Collaborating with cross-functional teams including IT, quality assurance, and operations to define validation strategies, manage risks, and ensure timely delivery of validation deliverables.
• Preparing and reviewing technical documentation such as validation plans, functional specifications, traceability matrices, test scripts, and summary reports to meet regulatory and client requirements.
• Supporting regulatory inspections and internal audits by providing technical expertise and ensuring all CSV documentation is audit-ready and aligned with the expectations 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 computer system validation within the Life Sciences industry, including pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of relevant regulatory guidelines including GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles, with a demonstrated ability to apply these in real-world project settings.
• Excellent analytical and problem-solving skills, with a structured approach to risk assessment, issue resolution, and the ability to manage multiple validation projects simultaneously.
• A degree in Computer Science, Engineering, Life Sciences, or a related field, combined with a proactive mindset, strong attention to detail, and a commitment to quality and compliance.
• Proficiency in both French and/or Dutch, as well as English, enabling effective communication in Brussels' multilingual professional environment.

What you'll love about working here

• Own your Growth: 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. Our engineering academy offers more than 60,000 hours of training to support your professional development.

• Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.

• Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.