Application Programming Interface (API), Biology, Business Analysis, Cadence, Change Control, Code of Federal Regulations, Contract Requirements, Cross-Functional, DeltaV, ERP (Enterprise Resource Planning), Ecosystems, Enterprise Architecture, Environmental Monitoring, Error Handling, GMP (Good Manufacturing Practices), Gap Analysis, GxP, ISA Standards, Information Technology & Information Systems, Laboratory Information Management System (LIMS), Labware, Leadership, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing/Industrial Processes, Middleware, Middleware Architecture, Open Systems Interconnection (OSI), Process Modeling, Process Validation, Project/Program Management, Quality Assurance, Quality Metrics, RAID Storage, REST (Representational State Transfer), Recipe Development, Requirements Management, SAP ECC (fka SAP R/3 and SAP ERP), SAP MM, SAP NetWeaver Process Integration (SAP PI), SOAP (Simple Object Access Protocol), Software Development Lifecycle (SDLC), Supervisory Control and Data Acquisition (SCADA), Supply Chain, System Integration (SI), System Validation, Technical/Engineering Design, Time Management, Vendor/Supplier Management, Warehousing
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.
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 (EBR) 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 (MBR) 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/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.