CSV Validation Engineer — Global, Hybrid, Growth

Capgemini Engineering; Fundão; Híbrido; EUR 35 000 - 55 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health and life insurance

Training and certifications in cutting-edge technologies

Referral program with bonuses

Career growth opportunities

Resumo da oferta

Capgemini Engineering in Fundão, Portugal is looking for a professional specialized in Computer System Validation (CSV) to ensure compliance with GxP guidelines. You will plan, define, and execute CSV activities and develop essential validation documentation.

The ideal candidate has a relevant academic background, strong experience in regulated environments, and excellent communication skills. The role offers a hybrid working model and emphasizes career growth in a supportive atmosphere.

Qualificações

• Strong experience in Computer System Validation (CSV) within regulated environments.
• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ).
• Proven ability to ensure full traceability and high-quality documentation.

Responsabilidades

• Plan, define, and execute Computer System Validation (CSV) activities.
• Develop and maintain validation documentation, including Validation Plans and User Requirement Specifications.
• Translate business and regulatory requirements into validation deliverables.

Conhecimentos

Computer System Validation (CSV)

GxP compliance standards

Strong communication skills

Detail-oriented approach

Fluency in English

Formação académica

Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or a related field

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.