CSV MES Engineer - Brussels Region
1 dag geleden
Functieomschrijving
The
CSV Specialist
is responsible for the implementation, validation, and lifecycle management of a Manufacturing Execution System (MES) within a GMP-regulated pharmaceutical manufacturing environment. The role ensures that the MES is designed, configured, qualified, and maintained in compliance with EU GMP Annex 11, Annex 15, FDA 21 CFR Part 11, and GAMP 5 requirements.
The position acts as the key validation lead for MES deployment, overseeing electronic batch record (EBR) design, system integration, and ensuring data integrity, compliance, and inspection readiness.
- Lead the CSV lifecycle for MES implementation (URS, FS/DS review, risk assessments, validation planning, IQ/OQ/PQ execution, and validation reporting).
- Ensure system compliance with data integrity principles (ALCOA+) and electronic records/electronic signatures requirements.
- Oversee configuration and validation of Electronic Batch Records (EBR), ensuring alignment with process requirements and regulatory expectations.
- Manage system integration with ERP, LIMS, DCS/SCADA, and other automation platforms.
- Perform and document risk assessments (SRA, FMEA) and define test strategies based on GAMP 5 methodology.
- Support change control, deviation management, CAPA, and periodic review activities.
- Collaborate cross-functionally with QA, IT, Automation, Engineering, and Production teams during implementation and go-live phases.
- Provide SME support during audits and regulatory inspections.
- Develop and maintain validation documentation, SOPs, and lifecycle management procedures.
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