CSV Validation Engineer – Hybrid, GxP & GAMP5

Capgemini; Lisboa; Híbrido; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health and life insurance

Career growth programs

Hybrid work model

Resumo da oferta

Capgemini is seeking a Validation Engineer in Lisboa to lead Computer System Validation (CSV) activities adhering to GxP guidelines. The role involves planning, defining, and executing validation activities while maintaining high-quality documentation and traceability.

The ideal candidate will have a strong academic background in Pharmaceutical Sciences or Engineering and proven experience in regulated environments. Enjoy a hybrid work model and comprehensive career growth opportunities with Capgemini.

Qualificações

• Strong experience in Computer System Validation (CSV) within regulated environments.
• Proven ability to translate business and regulatory requirements into validation deliverables.
• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ).

Responsabilidades

• Plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines.
• Develop and maintain validation documentation, including Validation Plans (VP) and User Requirement Specifications (URS).

Conhecimentos

Computer System Validation (CSV)

GxP

GAMP5

Fluency in English

Formação académica

Academic background in Pharmaceutical Sciences, Life Sciences or Engineering

Descrição da oferta de emprego

Capgemini is seeking a Validation Engineer in Lisboa to lead Computer System Validation (CSV) activities adhering to GxP guidelines. The role involves planning, defining, and executing validation activities while maintaining high-quality documentation and traceability.

The ideal candidate will have a strong academic background in Pharmaceutical Sciences or Engineering and proven experience in regulated environments. Enjoy a hybrid work model and comprehensive career growth opportunities with Capgemini.