MES / Manufacturing Systems SME

Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems. This is an owner-side, program-focused role requiring coordination across multiple stakeholders, suppliers, and delivery teams rather than a narrowly scoped execution-only assignment.

Responsibilities

Translate manufacturing and quality requirements into MES, EBR, recipe, workflow, and master-data solutions; Support MES architecture, design reviews, requirements, configuration oversight, testing, validation, deployment, and stabilization; Coordinate interfaces with DCS/PLC/SCADA, ERP, LIMS, historians, CMMS, and data platforms; Support business process mapping, electronic record design, exception handling, data integrity, and operational readiness; Partner with manufacturing, quality, automation, IT/OT, CSV, and system integrators

Requirements

Bachelor's degree in engineering, computer science, information systems, or related field, or equivalent experience; 8+ years of MES or manufacturing systems experience in pharmaceutical or biotech manufacturing; Hands-on experience with EBR/MBR design, recipe/workflow configuration, MES validation, and regulated manufacturing processes; Experience with one or more enterprise MES platforms and integrations using ISA-88/ISA-95 concepts

Nice to have

Experience on a greenfield or major capital pharmaceutical manufacturing program; Demonstrated success operating in an owner-side, EPCM, governance, or provider-oversight model; Strong written communication, executive reporting, facilitation, and cross-functional issue-resolution skills; Ability to maintain significant site presence as the program advances

Benefits

Premium medical coverage; 401(k) with company match; Tuition reimbursement; Unique performance incentives; Employee Stock Ownership Plan (ESOP)