CSV Engineer: Life Sciences & Med Devices (GxP)

Capgemini Engineering; Porto; Hybrid; EUR 35,000 - 60,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral bonuses

Office locations

Job summary

Capgemini Engineering seeks a professional to plan, define and execute Computer System Validation activities in compliance with GxP guidelines. The role includes developing and maintaining validation documentation such as VP, URS, FS/DS and IQ/OQ/PQ protocols and reports.

The candidate will work in an international, multicultural team with English as the primary language, contributing to high-quality, traceable validation deliverables.

Qualifications

• Academic background in regulated environments (pharma/biotech/engineering).
• Strong experience in Computer System Validation (CSV) with GxP, GAMP5.
• Ability to translate requirements into validation deliverables with full traceability.

Responsibilities

• Plan, define and execute CSV activities.
• Develop and maintain validation documentation (VP, URS, FS/DS).
• Prepare IQ/OQ/PQ protocols and reports.
• Collaborate in international, multicultural teams and communicate in English.

Skills

CSV expertise

GxP compliance

Regulated environments

IQ/OQ/PQ experience

English fluency

Education

Pharma/Life Sciences

Engineering background

Job description

Capgemini Engineering seeks a professional to plan, define and execute Computer System Validation activities in compliance with GxP guidelines. The role includes developing and maintaining validation documentation such as VP, URS, FS/DS and IQ/OQ/PQ protocols and reports.

The candidate will work in an international, multicultural team with English as the primary language, contributing to high-quality, traceable validation deliverables.