CSV Engineer (Lifesciences & Medical Devices)

Capgemini; Lisboa; Hybrid; EUR 35,000 - 55,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral program

Great office locations

Job summary

Capgemini is seeking a CSV Engineer for Lifesciences & Medical Devices projects in Lisbon. The role focuses on planning, defining, and executing CSV activities in compliance with GxP guidelines and regulatory standards.

You will develop validation documentation and ensure full traceability across URS, FS/DS, IQ/OQ/PQ artifacts. The ideal candidate has strong CSV experience in regulated environments, with hands-on validation lifecycle expertise and excellent communication skills in English,

Qualifications

• Strong experience in Computer System Validation (CSV) within regulated environments (pharmaceutical, biotech).
• Solid knowledge of GxP, GAMP5, and compliance standards.
• Ability to translate business and regulatory requirements into validation deliverables with full traceability.
• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ).
• Comfortable working in international, multicultural teams with fluent English.

Responsibilities

• Plan, define, and execute CSV activities in compliance with GxP guidelines (e.g., GAMP5, FDA, EMA).
• Develop and maintain validation documentation including VP, URS, FS/DS, IQ/OQ/PQ protocols and reports.

Skills

CSV expertise

GxP knowledge

Regulated environments

English fluency

Education

Pharmaceutical/Life Sciences or Engineering

Job description

# CSV Engineer (Lifesciences & Medical Devices)Lisboa - Expo, VNG - Cais GaiaApply for this job* Permanent* Experienced Professionals* Manufacturing & Operations Engineering* ID 586893-en\\_US## **CSV ENGINEER**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.