US_East | Manufacturing & Process Engineer_L

POMS Techno Functional SME

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.

Work Location:

Albany, New York (onsite candidates preferred)

Start date:

Immediate availability. Background check MANDATORY

Role Overview:
Role – POMS Techno functional SME Experience – 8 to 12 Years Domain :
Life Science/Pharma & MES

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.

• 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:
• 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.

• Support CSV (Computer System Validation) activities.
• 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.

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.