CSV Engineer: Regulated Systems, Hybrid, Growth

Capgemini Engineering; Porto; Híbrido; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health and life insurance

Career growth programs

Hybrid work

Training and certifications

Referral program with bonuses

Resumo da oferta

Capgemini Engineering in Porto is looking for a Computer System Validation (CSV) specialist to ensure compliance with GxP guidelines. You will play a key role in developing and maintaining validation documentation within a multicultural and supportive team atmosphere.

The ideal candidate has a strong background in Pharmaceutical Sciences, experience in regulated environments, and excellent communication skills. The position offers a hybrid work model and opportunities for career growth and training.

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).
• Comfortable working in international, multicultural teams.

Responsabilidades

• Plan, define, and execute Computer System Validation activities in compliance with GxP Guidelines.
• Develop and maintain validation documentation, including Validation Plans, User Requirement Specifications, and protocols.

Conhecimentos

Computer System Validation (CSV)

GxP compliance standards

Strong communication skills

Detail-oriented approach

English fluency

Formação académica

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

Descrição da oferta de emprego

Capgemini Engineering in Porto is looking for a Computer System Validation (CSV) specialist to ensure compliance with GxP guidelines. You will play a key role in developing and maintaining validation documentation within a multicultural and supportive team atmosphere.

The ideal candidate has a strong background in Pharmaceutical Sciences, experience in regulated environments, and excellent communication skills. The position offers a hybrid work model and opportunities for career growth and training.