POMS Techno functional SME

Role name: POMS Techno functional SME
Work Location Albany, New York  (On Site)
Duration: 12+ Months

 
Role Overview:
Role – POMS Techno functional SME
Experience – 8 to 12 Years
Domain: Life Science/Pharma & MES
Location: Albany, New York (onsite candidates preferred)
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.