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Job Title: Computer System Validation (CSV) Consultant – MES Systems Integration

Start Date: ASAP

End Date: 31/12/2026

Location: Antwerpen

Work Regime: Full-time, hybrid

Responsibilities:

• Project & Stakeholder Management:
  • Collaborate within a cross-functional project team in a dynamic environment with changing priorities.
  • Support project planning and execution activities.
  • Participate in project meetings, workshops, testing sessions, and stakeholder reviews.
  • Communicate project risks, issues, and progress proactively.
  • Support change control activities and documentation.
• Master Batch Record Design & Review:
  • Ensure lean transition of current MBRs/master recipes and other MES functionalities/reports into PAS-X.
  • Review master recipes ensuring GxP-compliance, integration of critical process parameters, and alignment with validation and registration files.
  • Support review by exception opportunities and vertical integration initiatives.
  • Support structured and uniformized Master Data setup.
• Computer System Validation (CSV):
  • Execute CSV activities in accordance with GxP requirements and procedures.
  • Author, review, and execute validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, Test Scripts, and Validation Summary Reports.
  • Ensure validation deliverables are inspection- and audit-ready.
  • Support quality assurance reviews and approval activities.
• Testing & System Implementation:
  • Prepare, review, and execute validation and user acceptance testing protocols.
  • Coordinate testing activities with business stakeholders and SMEs.
  • Document test evidence, deviations, defects, and corrective actions.
  • Support system integration testing and end-to-end business process validation.
  • Verify that implemented solutions meet business and compliance requirements.
• Business Process Analysis & Requirements Management:
  • Document and analyze existing manufacturing business processes and system workflows.
  • Support process mapping and future-state process design activities.
  • Gather, review, challenge, and document business and user requirements.
  • Assist in the preparation and review of User Requirement Specifications (URS).
  • Support fit-gap assessments between current processes and target system capabilities.
  • Ensure requirement traceability throughout the validation lifecycle.
• Change Management & Training:
  • Support deployment and adoption of new systems and business processes.
  • Create and update SOPs, work instructions, and supporting documentation.
  • Develop training materials and deliver end-user training.
  • Support organizational readiness and communication activities.
  • Assist operational teams during implementation and hypercare phases.

Required Skills & Experience:

• Medior profile with minimum 3 years of relevant experience.
• Experience in pharmaceutical, biotechnology, or life sciences manufacturing environments.
• Experience in Computer System Validation within a GxP-regulated environment.
• Experience supporting implementation or migration of regulated computerized systems.
• Strong understanding of validation lifecycle documentation and testing methodologies.
• Experience with requirements gathering, business process analysis, and fit-gap assessments.
• Experience writing or reviewing SOPs and procedural documentation.
• Strong stakeholder management and communication skills.
• Experience with MES, LIMS, QMS, SAP-based solutions, and other regulated GxP applications.
• Knowledge of data migration and master data concepts is considered an asset.

Languages:

Fluent in Dutch and English.