CSV Engineer, Life Sciences & Med Devices - Hybrid

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

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,