Role: MES Program Manager Duration:11+ Months Role: Foster City, CA - onsite
Must Have's: • 10+ years of IT program or project management experience, with a minimum of 5 years specifically managing MES implementations in Life Sciences, Biopharma, or GMP-regulated manufacturing • ERP Integration: SAP S/4HANA PP/MM/EWM or equivalent ERP, covering production order execution, material consumption (goods issue/receipt), batch/lot management, and MES–EWM warehouse staging flows. • Enterprise ecosystem: functional understanding of LIMS (Labware, Benchling, or equivalent), QMS/QDMS (Veeva Vault or equivalent), Historian (OSI PI or equivalent), and IT/OT (OPC UA/DA, DeltaV, SCADA). • Integration architecture: IDocs, REST/SOAP APIs, SAP PI/PO or equivalent middleware; understanding of synchronous vs. asynchronous messaging, error handling, and integration monitoring in GMP environments. • GxP/CSV: GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, IQ/OQ/PQ protocols, RTM structure, and change control governance in a validated system environment.
Description: • Own and manage the full MES program lifecycle — pre-implementation, implementation, testing, and go-live — for Werum PAS-X • Lead the definition and delivery of all MES pre-implementation outputs: scope statement, process design confirmation, functional requirements, data readiness, fit-gap analysis, and implementation timeline. • Oversee Electronic Batch Record (EBR) design and workflow development, ensuring manufacturing processes are correctly modeled in PAS-X aligned with ISA-88 standards. • Drive the fit-gap analysis process, coordinating business analysts and SMEs to identify gaps between standard PAS-X capabilities and NCF business requirements, with resolution strategies documented. • Manage MES vendor and system integrator relationships, holding delivery teams accountable to milestones, quality standards, and contractual obligations. • Oversee MES configuration, recipe authoring, master batch record (MBR) design, and system validation activities in coordination with QA and validation teams. • Lead the end-to-end integration program between MES (PAS-X) and ERP (SAP S/4HANA or equivalent), defining all interface touchpoints, data flows, and middleware architecture. • Establish and maintain program governance structures: integrated master schedule, RAID log, decision register, change control log, and steering committee reporting cadence. • Define and track program milestones across MES, integration, and validation workstreams, providing timely escalation when scope, schedule, or quality risks emerge. • Facilitate cross-functional workshops, design reviews, and integration alignment sessions across Manufacturing, Quality, IT/OT, Supply Chain, and Enterprise Architecture teams. • Communicate program status, risks, and key decisions to senior leadership and executive sponsors in clear, concise, and executive-ready formats. • Ensure all MES and integration deliverables comply with GMP, GxP, 21 CFR Part 11, GAMP 5, and ALCOA+ requirements throughout the program lifecycle.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.
