About this role
Roles & Responsibilities
- Configure and develop electronic batch records (eBR) using Werum PAS‑X
- Perform workflow configuration using MBR Designer / PAS‑X tools
- Support FAT, SAT, and validation activities (IQ/OQ)
- Assist in integration with SAP and automation systems (DeltaV / PLCs)
- Provide shopfloor MES support during batch execution
- Troubleshoot workflow, master data, and interface issues
- Support change control, deviations, and SOP documentation
- Participate in system upgrades and continuous improvement initiatives
Requirements
- 6 to 8 years of MES experience in pharma/biotech
- Hands‑on experience with Werum PAS‑X configuration
- Strong knowledge of eBR design, workflow configuration, and MES support in live manufacturing environments
- Good understanding of cGMP, GAMP 5, 21 CFR Part 11, ISA‑88 / ISA‑95 fundamentals
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