POMS MES Techno-Functional Consultant

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. ob Title: Digital MES Engineer – POMS MES (Techno-Functional SME) Location: Albany, NY (Preferred) Duration: Long-Term Contract Interview: Background Check & Meet-and-Greet Mandatory Job Description Capgemini is seeking an experienced Digital MES Engineer – POMS MES (Techno-Functional SME) to support digital manufacturing initiatives within a GxP-regulated pharmaceutical manufacturing environment. This role requires expertise in POMS MES, Electronic Batch Records (EBR), pharmaceutical manufacturing processes, Computer System Validation (CSV), and regulatory compliance. The ideal candidate will bridge manufacturing operations, quality, validation, and IT teams while configuring, supporting, enhancing, and implementing POMS MES solutions across manufacturing sites. Key Responsibilities • Gather and analyze business requirements from Manufacturing, Quality, Validation, and IT stakeholders. • Configure, enhance, and support POMS MES applications, Electronic Batch Records (EBR), recipes, and production workflows. • Translate business needs into functional specifications, solution designs, and implementation plans. • Support MES implementations, upgrades, migrations, deployments, and production support activities. • Troubleshoot production issues, perform root cause analysis, and implement corrective actions. • Integrate MES with ERP, LIMS, SCADA, Historians, and automation systems. • Lead fit-gap analysis, UAT, process improvements, and manufacturing workflow optimization. • Support Computer System Validation (CSV) activities, including URS, FRS, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports. • Ensure compliance with FDA 21 CFR Part 11, GAMP 5, GMP, GxP, ALCOA+, and Data Integrity standards. • Collaborate with cross-functional teams to support digital manufacturing transformation initiatives. Required Skills • 8–12 years of experience in Pharmaceutical, Biotechnology, or Life Sciences manufacturing. • 5+ years of hands-on experience with POMS MES implementation or support. • Strong knowledge of Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), batch execution, and production workflows. • Experience working in GxP-regulated environments. • Hands-on experience with Computer System Validation (CSV) and validation documentation (URS, FRS, IQ, OQ, PQ, VSR). • Knowledge of FDA 21 CFR Part 11, GAMP 5, GMP, ALCOA+, and Data Integrity. • Experience integrating MES with ERP, LIMS, SCADA, Historians, and automation platforms. • Strong analytical, troubleshooting, communication, and stakeholder management skills. Preferred Skills • Large-scale MES implementation or multi-site rollout experience. • Knowledge of ISA-95 manufacturing standards. • Experience supporting global pharmaceutical manufacturing organizations. • Familiarity with Agile and hybrid project delivery methodologies. This role is ideal for experienced MES professionals with a strong background in pharmaceutical digital manufacturing, regulatory compliance, and POMS MES solution delivery.