Validation Engineer

Capgemini Engineering; Fundão; Hybrid; EUR 40,000 - 65,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral program with bonuses

Career growth programs

Job summary

Capgemini Engineering is seeking a CSV professional to plan, define and execute validation activities in regulated environments. You will develop and maintain comprehensive validation documentation, including URS, FS/DS, IQ/OQ/PQ, and VP.

The role requires strong experience with GxP, GAMP5, and regulatory standards, with clear traceability from requirements to validated deliverables. You will collaborate with international teams and benefit from hybrid work arrangements.

Qualifications

• Strong experience in Computer System Validation (CSV) within regulated environments.
• Solid knowledge of GxP, GAMP5, and compliance standards.
• Translate business and regulatory requirements into validation deliverables with traceability.
• Hands-on validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ) with attention to detail.
• Excellent communication and ability to work in international teams; English required.

Responsibilities

• Plan, define, and execute CSV activities in compliance with GxP guidelines.
• Develop and maintain validation documentation (VP, URS, FS/DS, IQ/OQ/PQ protocols and reports).

Skills

CSV experience

GxP knowledge

GAMP5 familiarity

Regulatory documentation

English fluency

Education

Pharmaceutical Sciences / Life Sciences / Engineering 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 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

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

YOUR PROFILE

• 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

What You'll Love About Working Here

• 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 an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology, and people. With our strong heritage of nearly 60 years, we are a responsible and diverse group of 420,000 team members in more than 50 countries. We deliver end-to‑end services and solutions with our deep industry expertise and strong partner ecosystem, leveraging our capabilities across strategy, technology, design, engineering and business operations.