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CSV Engineer (Lifesciences & Medical Devices)

Hybrid in Vila Nova de Gaia·Added yesterday (last checked 28 Oct)

Capgemini

282 open roles

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Our summary

Work mode: Hybrid, Vila Nova de Gaia

Skills

Life Sciences

The 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

WHAT YOU´LL LOVE ABOUT WORKING HERE

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.

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.

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

Hiring process

1 interview

Submitting your application takes 3 to 5 minutes (name, contact details, CV and optional cover letter).
When you accept the offer you receive a pre-boarding plan and an invitation to the monthly RISE welcome event.

About Capgemini

Capgemini is a global leader in consulting, technology services and digital transformation, offering an array of integrated services that combine technology with deep sector expertise. The group describes itself as a global leader in business and technology transformation, powered by AI, and serves industries including aerospace and defense, banking and capital markets, consumer products, energy and utilities, healthcare, insurance, manufacturing, public sector, retail and telecoms.

Its portfolio of brands includes Capgemini Invent, its powerhouse of innovation, design and transformation, Capgemini Engineering, which helps the world's largest innovators engineer the products and services of tomorrow, as well as frog and Sogeti. Its services span cloud, cybersecurity, data and artificial intelligence, digital sovereignty, enterprise management, intelligent industry and sustainable business.

Industry: IT Consulting
Employees: 350,000

In their own words

About the company & team

Capgemini is the business transformation partner for enterprises in the age of AI. We help organizations imagine and build an intelligent, sustainable future, combining AI, technology and human ingenuity to transform how they operate, innovate and grow. With unique end-to-end capabilities spanning strategy, technology, engineering and intelligent operations, we bring together deep industry expertise and market-leading capabilities in AI, cloud and data to turn ambition into measurable business outcomes at scale. Supported by a robust ecosystem of partners and nearly 60 years of expertise, Capgemini is a responsible and diverse global organization of over 410,000 team members in more than 50 countries.

All open roles at Capgemini