CSV Validation Engineer — Hybrid, Global Pharma Impact

Capgemini Engineering; Fundão; Híbrido; EUR 42 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work

Health and life insurance

Referral program with bonuses

Great office locations

Career growth and training programs

Resumo da oferta

Capgemini Engineering is seeking a CSV Validation Specialist to define, plan and execute Computer System Validation activities in regulated environments, aligned with GxP guidelines.

The role focuses on developing validation artifacts (URS, FS/DS, IQ/OQ/PQ) and ensuring full traceability and compliant documentation across global teams. English fluency and strong communication are essential for collaboration.

Qualificações

• Experience in CSV within regulated environments (pharmaceutical/biotech).
• Strong knowledge of GxP, GAMP5, and compliance standards.
• Ability to translate requirements into validation deliverables with full traceability.

Responsabilidades

• Plan, define, and execute CSV activities in compliance with GxP guidelines.
• Develop and maintain validation documentation (VP, URS, FS/DS, IQ/OQ/PQ).
• Ensure traceability and high-quality documentation across the validation lifecycle.
• Collaborate with international, multicultural teams and communicate effectively in English.
• Translate business and regulatory requirements into validation deliverables.

Conhecimentos

CSV experience

GxP knowledge

Documentation

Traceability

Communication

Formação académica

Academic background in Pharmaceutical Sciences, Life Sciences, Engineering, or related field

Ferramentas

Validation lifecycle

Descrição da oferta de emprego

Capgemini Engineering is seeking a CSV Validation Specialist to define, plan and execute Computer System Validation activities in regulated environments, aligned with GxP guidelines.

The role focuses on developing validation artifacts (URS, FS/DS, IQ/OQ/PQ) and ensuring full traceability and compliant documentation across global teams. English fluency and strong communication are essential for collaboration.