Validation Engineer

Capgemini; Lisboa; Presencial; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health and life insurance

Career growth programs

Hybrid work model

Resumo da oferta

Capgemini is seeking a Validation Engineer in Lisboa to lead Computer System Validation (CSV) activities adhering to GxP guidelines. The role involves planning, defining, and executing validation activities while maintaining high-quality documentation and traceability.

The ideal candidate will have a strong academic background in Pharmaceutical Sciences or Engineering and proven experience in regulated environments. Enjoy a hybrid work model and comprehensive career growth opportunities with Capgemini.

Qualificações

• Strong experience in Computer System Validation (CSV) within regulated environments.
• Proven ability to translate business and regulatory requirements into validation deliverables.
• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ).

Responsabilidades

• Plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines.
• Develop and maintain validation documentation, including Validation Plans (VP) and User Requirement Specifications (URS).

Conhecimentos

Computer System Validation (CSV)

GxP

GAMP5

Fluency in English

Formação académica

Academic background in Pharmaceutical Sciences, Life Sciences or Engineering

Descrição da oferta de emprego

# Validation EngineerVNG - Lake Towers, Lisboa - Expo, FundãoApply for this job* Permanent* Experienced Professionals* Software Engineering* ID 227090-en\_GBAt 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 ROLEPlan, 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.