Validation Engineer

Capgemini Engineering; Fundão; Presencial; EUR 42 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work

Health and life insurance

Referral program with bonuses

Great office locations

Career growth and training programs

Resumo da oferta

Capgemini Engineering is seeking a CSV Validation Specialist to define, plan and execute Computer System Validation activities in regulated environments, aligned with GxP guidelines.

The role focuses on developing validation artifacts (URS, FS/DS, IQ/OQ/PQ) and ensuring full traceability and compliant documentation across global teams. English fluency and strong communication are essential for collaboration.

Qualificações

• Experience in CSV within regulated environments (pharmaceutical/biotech).
• Strong knowledge of GxP, GAMP5, and compliance standards.
• Ability to translate requirements into validation deliverables with full traceability.

Responsabilidades

• Plan, define, and execute CSV activities in compliance with GxP guidelines.
• Develop and maintain validation documentation (VP, URS, FS/DS, IQ/OQ/PQ).
• Ensure traceability and high-quality documentation across the validation lifecycle.
• Collaborate with international, multicultural teams and communicate effectively in English.
• Translate business and regulatory requirements into validation deliverables.

Conhecimentos

CSV experience

GxP knowledge

Documentation

Traceability

Communication

Formação académica

Academic background in Pharmaceutical Sciences, Life Sciences, Engineering, or related field

Ferramentas

Validation lifecycle

Descrição da oferta de emprego

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.