MES Engineer - PAS -X

1. 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

1. 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)