MES Program Manager Werum PAS-X (Life Sciences Manufacturing)

ICONMA, LLC

Foster City, CA

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JOB DETAILS

SALARY

$16.50–$57.14 Per Hour

SKILLS

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, Health Plan, ISA Standards, Information Technology & Information Systems, Information Technology Consulting, 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

LOCATION

Foster City, CA

POSTED

18 days ago

Our client, a IT Services and Consulting company, is looking for a MES Program Manager – Werum PAS-X (Life Sciences Manufacturing) for their Foster City, CA location.

Responsibilities:

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.
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.

Requirements:

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
Years of Experience: 14.00 Years of Experience

Skills:

Category Name Required Importance Experience
Areas of Expertise LS Yes 1
Manufacturing Execution Systems Werum PAS-X Yes 1

Why Should You Apply?

Health Benefits
Referral Program
Excellent growth and advancement opportunities

MES Program Manager Werum PAS-X (Life Sciences Manufacturing)

ICONMA, LLC

Foster City, CA

About the Company

ICONMA, LLC

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