MES (POMSNet)
Senior MES Engineer – POMS Net
Experience: 15+ Years Industry: Pharmaceutical / Life Sciences Location: USA (Remote – must be USA‑based)
Role Summary
We are seeking a highly experienced Senior MES Engineer – POMS Net with deep pharmaceutical manufacturing expertise. The role will lead and support POMS Net MES design, implementation, integration, and lifecycle management across regulated manufacturing environments, ensuring full GxP and data integrity compliance.
Key Responsibilities
- Lead POMS Net MES solution design, configuration, and deployment for pharma manufacturing sites
- Act as SME for manufacturing execution, electronic batch records (EBR), workflows, and recipes
- Drive end‑to‑end MES lifecycle activities including requirements, design, build, test, validation, deployment, and support
- Collaborate with Manufacturing, QA, Automation, IT, and CSV teams
- Support and lead computer system validation (CSV) activities in compliance with FDA, GxP, 21 CFR Part 11
- Ensure data integrity (ALCOA+) and audit readiness
- Manage MES integrations with ERP, LIMS, Historians, DCS/PLC systems
- Troubleshoot complex MES issues and drive continuous improvement initiatives
- Provide technical leadership, mentoring, and review of design documentation
- Participate in regulatory inspections and internal audits as MES SME