CSV Engineer for Life Sciences & Medical Devices (Hybrid)

Capgemini Engineering; Vila Nova de Gaia; Hybrid; EUR 30,000 - 52,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral program with bonuses

Career growth programs

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CSV validation

GxP knowledge

Regulatory compliance

English fluency

Education

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

Job description

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.