Validation Engineer
Capgemini • Fundão, Espírito Santo, Brazil
**Role & seniority: ** Computer System Validation (CSV) engineer / validation specialist (seniority not explicitly stated)
**Stack/tools: ** Validation lifecycle documentation & methods aligned to GxP and GAMP5; deliverables include VP, URS, FS/DS, IQ/OQ/PQ protocols and reports. (No specific software/tools stated.)
**Top 3 responsibilities: **
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Plan, define, and execute Computer System Validation activities in compliance with GxP (e.g., GAMP5, FDA, EMA)
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Develop and maintain validation documentation: Validation Plans (VP), URS, Functional/Design Specs (FS/DS)
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Create and execute IQ/OQ/PQ protocols/reports with full traceability to business & regulatory requirements
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Must-have skills:
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Prior CSV experience in regulated environments (pharmaceutical/biotech)
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Strong knowledge of GxP, GAMP5, and compliance expectations
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Ability to translate business/regulatory requirements into validation deliverables with traceability and high documentation quality
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Hands-on validation lifecycle execution (URS, FS/DS, IQ/OQ/PQ) with structured, detail-oriented work
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Good communication skills and English fluency for international teams
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Nice-to-haves:
- Not explicitly listed; likely domain breadth across additional regulated industries/projects (not specified)
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Location & work type:
- Hybrid work (specific location not provided)
Full 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.
