CSV Engineer – Life Sciences & Med Devices (Hybrid)

Capgemini Engineering; Porto; Hybrid; EUR 42.000 - 64.000; Vollzeit

Benefits dieser Stelle

Hybrid work

Health and life insurance

Referral program

Zusammenfassung

Capgemini Engineering Porto seeks a specialist to plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (GAMP5, FDA, EMA). You will develop and maintain validation documentation, including VP, URS, FS/DS, IQ/OQ/PQ protocols and reports.

You will work with international teams, translate regulatory requirements into validation deliverables, and ensure traceability and high-quality documentation.

Qualifikationen

• Experience in Computer System Validation (CSV) in regulated settings (pharma/biotech).
• Ability to translate regulatory requirements into validation deliverables with full traceability.

Aufgaben

• Plan, define and execute CSV activities per GxP guidelines (GAMP5, FDA, EMA).
• Develop and maintain validation documentation (VP, URS, FS/DS, IQ/OQ/PQ).
• Ensure high-quality, traceable documentation across validation lifecycle.

Kenntnisse

CSV experience

GxP knowledge

GAMP5

Regulated environments

Validation lifecycle

Documentation quality

English fluency

Ausbildung

Pharma/Life Sciences/Engineering degree

Jobbeschreibung

Capgemini Engineering Porto seeks a specialist to plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (GAMP5, FDA, EMA). You will develop and maintain validation documentation, including VP, URS, FS/DS, IQ/OQ/PQ protocols and reports.

You will work with international teams, translate regulatory requirements into validation deliverables, and ensure traceability and high-quality documentation.