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MES Engineer - PAS -X

Advanced Manufacturing Tech Solutions

2.7
2 reviews
Advanced Manufacturing Tech Solutions
Job Type   /   Job Level
Full-time   /   Fresh/Entry Level
Company Location
Ireland
  • 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 hypercare, 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)
Jobs in Ireland   »   Jobs in Dublin, County Dublin, Ireland   »   MES Engineer - PAS -X

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