CSV Engineer (Lifesciences & Medical Devices)

Capgemini Engineering; Vila Nova de Gaia; Ibrido; EUR 30.000 - 52.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work

Health and life insurance

Referral program with bonuses

Career growth programs

Descrizione del lavoro

Capgemini Engineering in Porto seeks a Computer System Validation (CSV) specialist to plan, define, and execute GxP‑compliant validation activities for regulated environments. You will develop validation documents (URS, FS/DS, IQ/OQ/PQ) and ensure traceability across validated systems.

The role involves working with international teams in a hybrid setup, with access to Capgemini's training and career growth programs, and exposure to cutting‑edge technologies in life sciences.

Competenze

• Experience in Computer System Validation within regulated environments (pharma/biotech).
• Solid knowledge of GxP, GAMP5, and compliance standards.
• Ability to translate business and regulatory requirements into validation deliverables with traceability.

Mansioni

• Plan, define, and execute CSV activities in compliance with GxP guidelines.
• Develop and maintain validation documentation including VP, URS, FS/DS, IQ/OQ/PQ protocols and reports.
• Ensure full traceability and high-quality documentation across validated systems.

Conoscenze

CSV validation

GxP knowledge

Regulatory compliance

English fluency

Formazione

Bachelor's degree in Pharmaceutical Sciences / Life Sciences / Engineering

Descrizione del lavoro

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.

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.

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

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.