CSV Engineer | Life Sciences

Capgemini; Diegem; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Capgemini Engineering in Brussels seeks a CSV Engineer to validate computerised systems in Life Sciences. You will develop and execute CSV protocols in line with GAMP 5, 21 CFR Part 11 and EU Annex 11, ensuring compliance across the life cycle.

You will lead validation for MES, LIMS, ERP and process control systems, collaborating with IT, QA and operations to manage risks and deliver on time. Documentation, audits, and regulatory inspections are integral to the role.

Qualifications

• 2+ years in computer system validation within Life Sciences.
• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity.
• Strong analytical and problem-solving skills with risk assessment.
• Degree in Computer Science, Engineering or Life Sciences and quality mindset.
• Proficiency in French and/or Dutch and English for Brussels environment.

Responsabilités

• Developing and executing CSV protocols per regulatory frameworks.
• Leading validation for MES, LIMS, ERP and process control systems.
• Collaborating with IT, QA and operations to define validation strategies.
• Preparing validation plans, specifications, traceability and reports.
• Supporting inspections and audits with audit-ready CSV documentation.

Connaissances

CSV validation

Regulatory knowledge

Analytical skills

Risk assessment

Multilingual communication

Cross-functional collaboration

Formation

Degree in Computer Science, Engineering or Life Sciences

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 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 RoleAs 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 ProfileWe 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 hereOwn 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.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.