CSV Engineer (Lifesciences & Medical Devices)

Capgemini Engineering; Porto; Hybrid; EUR 42,000 - 64,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral program

Job summary

Capgemini Engineering Porto seeks a specialist to plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (GAMP5, FDA, EMA). You will develop and maintain validation documentation, including VP, URS, FS/DS, IQ/OQ/PQ protocols and reports.

You will work with international teams, translate regulatory requirements into validation deliverables, and ensure traceability and high-quality documentation.

Qualifications

• Experience in Computer System Validation (CSV) in regulated settings (pharma/biotech).
• Ability to translate regulatory requirements into validation deliverables with full traceability.

Responsibilities

• Plan, define and execute CSV activities per GxP guidelines (GAMP5, FDA, EMA).
• Develop and maintain validation documentation (VP, URS, FS/DS, IQ/OQ/PQ).
• Ensure high-quality, traceable documentation across validation lifecycle.

Skills

CSV experience

GxP knowledge

GAMP5

Regulated environments

Validation lifecycle

Documentation quality

English fluency

Education

Pharma/Life Sciences/Engineering degree

Job description

CAPGEMINI ENGINEERING

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.

About Capgemini

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.