CSV Engineer — Life Sciences Compliance & Validation

Capgemini Engineering; Diegem; Hybrid; EUR 52,000 - 78,000; Full time

Job summary

Capgemini Engineering Belgium is seeking a CSV Engineer to ensure validation and compliance of computerised systems used in Life Sciences. You will develop and execute CSV protocols in line with GAMP 5, 21 CFR Part 11, EU Annex 11 and related regulations.

You will lead validation activities for MES, LIMS, ERP, and process control systems, collaborating with IT, QA and operations to define strategies, manage risks, and deliver audit-ready documentation.

Qualifications

• Minimum 2 years in computer system validation within Life Sciences.
• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11.
• Proficient in risk assessment and issue resolution.
• Degree in CS, Engineering, Life Sciences or related field.

Responsibilities

• Develop and execute CSV protocols per GAMP 5 and Part 11.
• Lead validation activities for MES, LIMS, ERP, and process control systems.
• Collaborate with IT, QA, and operations to define strategies and manage risks.
• Prepare validation plans, specifications, traceability matrices, test scripts, and reports.
• Support regulatory inspections and ensure audit-ready CSV documentation.

Skills

CSV validation

Regulatory knowledge

Risk assessment

Documentation skills

Cross-functional work

Education

BSc Computer Science

Engineering degree

Life Sciences degree

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 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 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.
  
  

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.