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Job Description
How You’ll Spend Your Day
- Design, configure, and maintain Electronic Master Batch Records (MBRs) in Werum PAS‑X MES
- Convert paper batch records into electronic workflows
- Configure process instructions, phases, operations, calculations, material handling, and equipment steps in PAS‑X
- Collaborate with Cross functional teams like, Manufacturing, QA, and IT.
- Support MES validation activities (IQ/OQ/PQ, CSV documentation)
- Create and maintain functional specifications, configuration documents, and SOPs
- Support UAT execution and defect resolution
- Troubleshoot MBR execution and production issues
- Ensure compliance with GMP, GAMP 5, 21 CFR Part 11.
- Support MES deployment, upgrades, and continuous improvement initiatives