Serve as a techno-functional POMS MES SME for pharmaceutical manufacturing. Configure, support, and implement MES solutions while bridging business, quality, validation, and IT teams. Ensure compliant electronic batch records, workflows, GMP/GxP operations, troubleshooting, documentation, and CSV validation. Support regulatory compliance with FDA 21 CFR Part 11 and GAMP 5. Experience with large-scale MES rollouts and ERP, LIMS, or SCADA integrations is advantageous.
Job Description
Role: Digital Engineer – POMS MES Location: Remote | Start: Immediate | Interview: Phone/Skype
Summary: Seeking a POMS MES Techno‑Functional SME for pharma manufacturing (GxP). Role bridges business, quality, validation, and IT to configure, support, and implement MES solutions ensuring compliance and operational excellence.
Must‑Have Skills:
8–12 yrs Pharma/Life Sciences exp, 5+ yrs POMS MES
Strong MES, EBR, workflows, GMP/GxP, CSV validation
Troubleshooting, documentation, compliance (FDA 21 CFR Part 11, GAMP 5)
Optional Skills:
Large‑scale MES rollout, ERP/LIMS/SCADA integration
ISA‑95, Agile/hybrid delivery, global manufacturing
Additional Information
All your information will be kept confidential according to EEO guidelines.
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