CSV Engineer–Life Sciences (GMP, Validation, IT/Automation)

Capgemini; Diegem; Remote; EUR 52,000 - 68,000; Full time

Job summary

Capgemini is seeking a CSV Engineer to operate in a highly regulated GMP environment, contributing to validation and lifecycle management of critical IT and automation systems. You will support the validation team across all CSV phases, maintaining documentation per URS, FS, DS, IQ, OQ, and PQ.

Ideal candidates hold a Master’s in a pharma-related field, with 1+ year GMP exposure, and a solid grasp of validation principles. Proficiency in Dutch and English is required for daily collaboration.

Qualifications

• Master’s degree in a pharmaceutical-related field is required.
• 1+ year of experience in a GMP-regulated environment.
• Basic understanding of validation principles and the V-model.
• Interest in quality management, compliance, and continuous improvement.

Responsibilities

• Perform CSV activities in accordance with quality standards.
• Prepare, review, and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ).
• Work according to the V-model and internal validation procedures.
• Support risk assessments, impact assessments, and change control activities.
• Ensure GMP compliance at all stages of validation.
• Collaborate with QA, IT, Engineering, and Operations teams; assist audits.

Skills

GMP experience

Validation principles

Analytical mindset

Dutch language

English language

Education

Master’s degree in pharma-related field

Job description

Capgemini is seeking a CSV Engineer to operate in a highly regulated GMP environment, contributing to validation and lifecycle management of critical IT and automation systems. You will support the validation team across all CSV phases, maintaining documentation per URS, FS, DS, IQ, OQ, and PQ.

Ideal candidates hold a Master’s in a pharma-related field, with 1+ year GMP exposure, and a solid grasp of validation principles. Proficiency in Dutch and English is required for daily collaboration.