MES Engineer – PAS-X (4–8 Years)
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
4–8 years of MES experience in pharma/biotech
Hands‑on experience with Werum PAS‑X configuration
Experience in:
eBR design and workflow configuration
MES support in live manufacturing environments
Good understanding of:
cGMP, GAMP 5, 21 CFR Part 11
ISA‑88 / ISA‑95 fundamentals
Senior MES Engineer – PAS-X (8+ Years)
Roles & Responsibilities
Lead PAS‑X solution design and eBR architecture using Werum PAS‑X
Own end‑to‑end MES lifecycle (design → build → deploy → support)
Configure and review complex eBRs and workflows
Lead validation strategy and execution (URS, FDS, IQ/OQ/PQ)
Drive integration with SAP, DeltaV, and PLC systems
Act as technical SME for PAS‑X across projects
Engage with Manufacturing, QA, IT, and Automation stakeholders
Lead hyper‑care, troubleshooting, and system stabilization
Drive continuous improvement, standardization, and audit readiness
Support project planning, timelines, and delivery execution
Requirements
4+ years of MES experience, with strong PAS‑X expertise
Deep hands‑on experience in:
eBR design and architecture
MBR Designer / PAS‑X modules
Strong knowledge of:
GAMP 5, 21 CFR Part 11, EU Annex 11
ISA‑88 / ISA‑95 standards
Experience in end‑to‑end MES project delivery
Strong exposure to CSV lifecycle (authoring + execution)
Experience in system integrations (SAP, DeltaV, PLCs)
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