CSV Validation Engineer - Regulated Systems, Hybrid

Capgemini Engineering; Fundão; Hybrid; EUR 40,000 - 65,000; Full time

Benefits offered by this job

Hybrid work

Health and life insurance

Referral program with bonuses

Career growth programs

Job summary

Capgemini Engineering is seeking a CSV professional to plan, define and execute validation activities in regulated environments. You will develop and maintain comprehensive validation documentation, including URS, FS/DS, IQ/OQ/PQ, and VP.

The role requires strong experience with GxP, GAMP5, and regulatory standards, with clear traceability from requirements to validated deliverables. You will collaborate with international teams and benefit from hybrid work arrangements.

Qualifications

• Strong experience in Computer System Validation (CSV) within regulated environments.
• Solid knowledge of GxP, GAMP5, and compliance standards.
• Translate business and regulatory requirements into validation deliverables with traceability.
• Hands-on validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ) with attention to detail.
• Excellent communication and ability to work in international teams; English required.

Responsibilities

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

Skills

CSV experience

GxP knowledge

GAMP5 familiarity

Regulatory documentation

English fluency

Education

Pharmaceutical Sciences / Life Sciences / Engineering degree

Job description

Capgemini Engineering is seeking a CSV professional to plan, define and execute validation activities in regulated environments. You will develop and maintain comprehensive validation documentation, including URS, FS/DS, IQ/OQ/PQ, and VP.

The role requires strong experience with GxP, GAMP5, and regulatory standards, with clear traceability from requirements to validated deliverables. You will collaborate with international teams and benefit from hybrid work arrangements.