POMS MES Techno-Functional SME
Core
Techno-functional SME for POMS MES in life sciences/pharma manufacturing, bridging business needs with MES implementation and support.
Role type
Senior Techno-Functional SME (MES)
Builds
POMS MES solutions, electronic batch records, and manufacturing execution workflows for pharma/biotech clients
Domain
Life Sciences / Pharmaceutical Manufacturing / Digital Manufacturing
Required skills
POMS MES implementation and support, MES concepts, electronic batch records, batch execution, manufacturing operations, GxP-regulated environments, pharmaceutical manufacturing processes, validation methods, quality systems, functional and technical documentation interpretation, troubleshooting, analytical problem-solving
Preferred skills
Large-scale MES implementations, site rollouts, ERP integrations, LIMS integrations, historian integrations, SCADA integrations, automation integrations, ISA-95 knowledge, digital manufacturing architectures, global manufacturing organization support
Technologies
POMS MES, ERP, LIMS, Historian, SCADA
Responsibilities
Gather, analyze, and document business needs with Manufacturing, Quality, Validation, and IT stakeholders; Convert business requirements into MES functional specifications, solution designs, and implementation plans; Lead requirements workshops, discovery sessions, fit-gap assessments, design reviews, and user acceptance testing; Partner with manufacturing teams to optimize production workflows and use POMS MES capabilities to improve operations; Align MES solutions with manufacturing processes, business goals, and regulatory requirements, and support process harmonization across sites; Configure, support, and enhance POMS MES workflows, electronic batch records, recipes, and manufacturing execution processes; Configure MES modules, troubleshoot issues, perform root cause analysis, and drive corrective actions for production support matters; Support and review MES integrations with ERP, LIMS, historians, automation/SCADA, and other manufacturing applications; Review technical specifications, configuration records, and implementation deliverables; assist with deployments, upgrades, migrations, and release management; Provide expertise in electronic batch record execution, deviation management, manufacturing investigations, and exception handling; Support computer system validation across the system lifecycle, including authoring, reviewing, and maintaining URS, FRS, design specifications, IQ, OQ, PQ, and validation summary reports; Help ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GMP requirements (via careerplan.io/jobs/g358bebf-poms-mes-techno-functional-sme-at-capgemini-engineering)