Validation Engineer

Plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (e.g., GAMP5, FDA, EMA)Develop and maintain validation documentation, including:

• Validation Plans (VP)

• User Requirement Specifications (URS)

• Functional and Design Specifications (FS/DS)

• IQ/OQ/PQ protocols and reports

• Academic background in Pharmaceutical Sciences, Life Sciences, Engineering, or a related field, ensuring understanding of regulated environments and industry practices

• Strong experience in Computer System Validation (CSV) within regulated environments (pharmaceutical, biotech), with solid knowledge of GxP, GAMP5, and compliance standards

• Proven ability to translate business and regulatory requirements into validation deliverables, ensuring full traceability and high-quality documentation

• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ) combined with a structured and detail-oriented approach

• Comfortable working in international, multicultural teams, with strong communication skills and fluency in English

• Join a multicultural and inclusive team environment.

• Enjoy a supportive atmosphere promoting work life balance.

• Hybrid work.

• Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities.

• Access valuable training and certifications in cutting edge technologies.

• Engage in exciting national and international projects.

• Health and life insurance.

• Referral program with bonuses for talent recommendations.

• Great office locations.

Capgemini is the business transformation partner for enterprises in the age of AI. We help organizations imagine and build an intelligent, sustainable future, combining AI, technology and human ingenuity to transform how they operate, innovate and grow. With unique end-to-end capabilities spanning strategy, technology, engineering and intelligent operations, we bring together deep industry expertise and market-leading capabilities in AI, cloud and data to turn ambition into measurable business outcomes at scale. Supported by a robust ecosystem of partners and nearly 60 years of expertise, Capgemini is a responsible and diverse global organization of over 410,000 team members in more than 50 countries.