What are the responsibilities and job description for the POMS Techno-Functional SME position at Net2Source (N2S)?
Job Title : POMS Techno-Functional SME
Job Location : Albany, NY(Onsite)
Job Duration :Long-term Contract(12 months)
Job Description:
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.
Key Responsibilities:
• 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 (EBR), 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.
Technical Responsibilities
• Configure and support POMS MES modules and integrations.
• Troubleshoot MES production issues and perform root cause analysis.
• Support interface development and integration with:
• Review technical specifications, configuration documents, and implementation deliverables.
• Support deployment, migration, and system upgrades.
• Knowledge of electronic batch records (EBR), batch execution, deviations, and manufacturing investigations.
GxP & Validation Responsibilities
• Support CSV (Computer System Validation) activities.
• Author and review:
o URS
o FRS
o Design Specifications
o IQ/OQ/PQ Protocols
o Traceability Matrix
o Validation Summary Reports
• Ensure compliance with:
o FDA 21 CFR Part 11
o GAMP 5
o GMP requirements
o Data Integrity guidelines
Desired Soft Skills
• 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.
Mandatory skills:
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.
Regards,
Vishwajeet Verma