CSV Engineer - MES Systems Integration

Pauwels Consulting; Puurs-Sint-Amands; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a Validation Specialist in Belgium to drive CSV activities and validation deliverables. You will author/review validation plans, risk assessments, and test scripts, while ensuring traceability and regulatory compliance.

You will collaborate on transitioning Master Batch Records into MES, coordinate testing, and support process mapping with requirement gathering. Fluency in Dutch and English is essential.

Qualifications

• 3+ years of experience in pharmaceutical, biotech, or life sciences manufacturing.
• Expertise in Computer System Validation within a GxP environment and testing methodologies.
• Experience supporting implementation or migration of regulated computerized systems.
• Skills in business process analysis and requirements management.
• Experience with regulated applications such as MES, LIMS, QMS, or SAP.
• Proactive communicator with experience writing technical SOPs and managing stakeholders.
• Fluent in Dutch and English.

Responsabilités

• Execute CSV activities including authoring/review of Validation Plans, Risk Assessments, and Test Scripts.
• Support lean transition of Master Batch Records and master recipes into the MES system.
• Coordinate testing activities and document evidence for deviations, defects, and CAPAs.
• Assist business process mapping and future-state design via requirements gathering and fit-gap assessments.
• Prepare and review User Requirement Specifications (URS) with traceability through validation lifecycle.
• Create and update SOPs and work instructions for readiness and training.

Connaissances

CSV expertise

GxP validation

Regulated system migration

Business process analysis

Requirements management

MES/LIMS/QMS/SAP experience

SOP writing

Stakeholder management

Dutch & English fluency

Outils

MES

LIMS

QMS

SAP

Description du poste

• 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.