CSV Engineer: MES Validation

• Execute Computer System Validation activities including the authoring and review of Validation Plans, Risk Assessments, and Test Scripts.
• 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.

Requirements

• 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 Haves

• Knowledge of data migration and master data concepts.
• Willingness to obtain specific MES platform training.