MES Engineer - PAS -X
Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) Dublin
- MES Engineer – PAS-X (4–8 Years)
- 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
- 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)
- 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 hypercare, troubleshooting, and system stabilization
- Drive continuous improvement, standardization, and audit readiness
- Support project planning, timelines, and delivery execution
- 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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