POMS MES Techno-Functional SME — Pharma

Capgemini Engineering; New York (NY); Hybrid; USD 104,000 - 174,000; Full time

Job summary

Capgemini Engineering seeks an experienced POMS MES Techno-Functional SME for a GxP-regulated pharmaceutical manufacturing environment in the US. You will bridge business stakeholders with IT and QA teams to support, configure, and implement MES across sites.

The role requires deep MES knowledge, hands-on POMS MES experience, and CSV/validation familiarity. Travel to manufacturing sites may be involved as needed.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or related field.
• 8–12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments.
• 5+ years of hands-on experience supporting or implementing POMS MES solutions.
• Strong understanding of MES concepts, EBR, batch execution, manufacturing operations, and production workflows.
• Experience working in GxP-regulated environments.
• Knowledge of validation methodologies and quality systems.
• Experience supporting MES implementations, enhancements, upgrades, and production support activities.

Responsibilities

• Collaborate with Manufacturing, Quality, Validation, and IT stakeholders to gather, analyze, and document business requirements.
• Translate business requirements into MES functional specifications, solution designs, and implementation strategies.
• Lead requirements workshops, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing (UAT).
• Partner with manufacturing teams to optimize production workflows and leverage POMS MES capabilities to improve operational performance.
• Drive alignment between MES solutions, manufacturing processes, business objectives, and regulatory requirements.
• Support process harmonization initiatives across manufacturing sites.
• Configure, support, and enhance POMS MES workflows, EBRs, recipes, and manufacturing execution processes.
• Review technical specifications, documentation, and implementation deliverables.
• Assist with deployments, upgrades, migrations, and release management.
• Provide expertise in EBR execution, deviations management, investigations, and exception handling.
• Support CSV activities throughout the system lifecycle.
• Maintain validation documentation (URS, FRS, DS, IQ, OQ, PQ, VSR).
• Ensure compliance with FDA 21 CFR Part 11, GAMP 5, GMP.

Skills

MES concepts

Electronic batch records (EBR)

Manufacturing operations

Production workflows

Validation methodologies

GxP compliance

Troubleshooting

Education

Bachelor's degree in Engineering or Life Sciences

Tools

ERP

LIMS

Historian

SCADA

POMS MES

Job description

Capgemini Engineering seeks an experienced POMS MES Techno-Functional SME for a GxP-regulated pharmaceutical manufacturing environment in the US. You will bridge business stakeholders with IT and QA teams to support, configure, and implement MES across sites.

The role requires deep MES knowledge, hands-on POMS MES experience, and CSV/validation familiarity. Travel to manufacturing sites may be involved as needed.