CSV Engineer
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Ensure the lean transition of Master Batch Records (MBR) and master recipes into the MES system.
Coordinate testing activities and document evidence for deviations, defects, and corrective actions.
Support business process mapping and future-state design activities through requirement gathering and fit-gap assessments.
Prepare and review User Requirement Specifications (URS) and ensure traceability throughout the validation lifecycle.
Create and update SOPs and work instructions to support organizational readiness and training.
You have 3+ years of relevant experience in pharmaceutical, biotechnology, or life sciences manufacturing environments.
You bring expertise in Computer System Validation (CSV) within a GxP-regulated environment and a strong understanding of testing methodologies.
You're experienced in supporting the implementation or migration of regulated computerized systems.
You possess skills in business process analysis and requirements management.
You have experience with regulated applications such as MES, LIMS, QMS, or SAP.
You're a proactive communicator with experience writing technical SOPs and managing stakeholder expectations.
You are fluent in Dutch and English.
Nice to HavesKnowledge of data migration and master data concepts.
Willingness to obtain specific MES platform training.
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CSV Engineer
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Computer System Validation
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Validation Engineer – CSV
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