CSV Engineer | Life Sciences Flanders

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

# CSV Engineer | Life Sciences FlandersDiegemApply for this job* Permanent* Experienced Professionals* Manufacturing & Operations Engineering* ID 424486-en\\_GB## Your roleIn this role, you will work in a highly regulated GMP environment, where quality, reliability, and continuous improvement are key priorities. You will be part of a multidisciplinary team that plays a crucial role in the validation and lifecycle management of critical IT and automation systems. As a CSV Engineer, you will support the validation team throughout all phases of Computer System Validation (CSV). You work in a structured and methodical manner and contribute to the operational excellence of our client. You will:* Perform CSV activities in accordance with established quality standards.* Prepare, review, and maintain validation documentation (including URS, FS, DS, IQ, OQ, and PQ).* Work according to the V-model and internal validation and quality procedures.* Support risk assessments, impact assessments, and change control activities.* Ensure GMP compliance at every stage of the validation process.* Collaborate closely with QA, IT, Engineering, and Operations teams to achieve consistent and sustainable results.* Actively contribute to the preparation and follow-up of audits and inspections.## Your role* You hold a Master’s degree in a pharmaceutical-related field.* You have 1+ year of experience in a GMP-regulated environment through an internship or initial professional experience.* You have a basic understanding of validation principles and are familiar with the V-model.* You have a strong interest in quality management, compliance, and continuous improvement.* You are detail-oriented, well-organized, and possess a strong analytical mindset.* You are fluent in Dutch and have professional working proficiency in English.## What you’ll love about working here* Continuous feedback: We take human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.* FlexAbroad: Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.* Digital campuses and academy: Our engineering academy offers more than 60,000 hours of training, as also our digital campus on GenAI, data or sustainability, support digital learning in the flow of work from awareness to expert certifications.