MES Program Mgr

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/4

HANA 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.

JD:

• Own and manage the full MES program lifecycle — pre-implementation, implementation, testing, and go-live — for Werum Client-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 (E ) design and workflow development, ensuring manufacturing processes are correctly modeled in Client-X aligned with ISA-88 standards.

• Drive the fit-gap analysis process, coordinating business analysts and SMEs to identify gaps between standard Client-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 (M ) design, and system validation activities in coordination with QA and validation teams.

• Lead the end-to-end integration program between MES (Client-X) and ERP (SAP S/4

HANA 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 work streams, 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.