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 Data Integrity Testing Specialist, you will play a crucial role in ensuring that all data generated, processed, and stored within GMP regulated systems is accurate, complete, secure, and compliant with global regulatory expectations. Working within the PSES (Product, Process & System Evaluation) department, you will help safeguard the integrity and reliability of analytical, manufacturing, and quality-related data.

In this role you will play a key role in:

• Performing comprehensive data integrity assessments, including audit trail reviews, user-access verification, and data lifecycle evaluations
• Evaluating the integrity of data generated by analytical instruments, computerized systems, and process equipment
• Identifying gaps, deviations, or risks related to data integrity and ensuring corrective/preventive actions are defined and implemented
• Reviewing and approving CSV-related documentation, including validation plans, URS, test protocols, change controls, and deviations
• Acting as a subject matter expert (SME) during audits and inspections for data integrity and CSV topics

Your profile

• Bachelor's or Master's degree in Science, Engineering, Pharmacy, IT, or a related field
• Minimum 3 years of experience in GMP regulated environments (Manufacturing, QA, QC or CSV)
• Strong understanding of GMP/GLP, EU Annex 11, data integrity regulations, and computer system validation principles
• Experience reviewing audit trails, data flows, system logs, and digital records
• Excellent communication skills with the ability to operate effectively in cross-functional environments

What you'll love about working here

• At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
• Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
• OUTfront, Women@Capgemini or CapAbility are 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.

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.