POMS Techno-Functional SME

Job Duration

Long-term Contract (12+ months)

Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.

• Gather and analyze business requirements from Manufacturing, Quality, Validation, and IT stakeholders.
• Translate business requirements into MES functional specifications and system designs.
• Configure and support POMS MES workflows, electronic batch records (E ), recipes, and manufacturing processes.
• Facilitate requirement workshops, fit-gap analyses, solution design reviews, and UAT sessions.
• Collaborate with manufacturing teams to optimize production processes through MES capabilities.
• Ensure MES solutions align with business processes, GMP requirements, and regulatory expectations.

• Configure and support POMS MES modules and integrations.
• Troubleshoot MES production issues and perform root cause analysis.
• Support interface development and integration with appropriate systems.
• Review technical specifications, configuration documents, and implementation deliverables.
• Support deployment, migration, and system upgrades.
• Knowledge of electronic batch records (E ), batch execution, deviations, and manufacturing investigations.

• Author and review:
  • URS
  • FRS
  • Design Specifications
  • IQ/OQ/PQ Protocols
  • Traceability Matrix
  • Validation Summary Reports
• Ensure compliance with:
  • FDA 21 CFR Part 11
  • GAMP 5
  • GMP requirements
  • Data Integrity guidelines

• Strong stakeholder management.
• Excellent communication and documentation skills.
• Ability to work with cross-functional global teams.
• Strong analytical and problem-solving abilities.
• Leadership in driving workshops, solution reviews, and issue resolution.

Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.