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

Iconma

  • Foster City, CA
  • 30+ days ago
  • $16.50–$57.14 Per Hour
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Skills

  • Application Programming Interface (API)unmatched
  • Biologyunmatched
  • Business Analysisunmatched
  • Cadenceunmatched
  • Change Controlunmatched
  • Code of Federal Regulationsunmatched
  • Contract Requirementsunmatched
  • Cross-Functionalunmatched
  • DeltaVunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • Ecosystemsunmatched
  • Enterprise Architectureunmatched
  • Environmental Monitoringunmatched
  • Error Handlingunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Gap Analysisunmatched
  • GxPunmatched
  • Health Planunmatched
  • ISA Standardsunmatched
  • Information Technology & Information Systemsunmatched
  • Information Technology Consultingunmatched
  • Laboratory Information Management System (LIMS)unmatched
  • Labwareunmatched
  • Leadershipunmatched
  • Manufacturingunmatched
  • Manufacturing Execution Systems (MES)unmatched
  • Manufacturing/Industrial Processesunmatched
  • Middlewareunmatched
  • Middleware Architectureunmatched
  • Open Systems Interconnection (OSI)unmatched
  • Process Modelingunmatched
  • Process Validationunmatched
  • Project/Program Managementunmatched
  • Quality Assuranceunmatched
  • Quality Metricsunmatched
  • RAID Storageunmatched
  • REST (Representational State Transfer)unmatched
  • Recipe Developmentunmatched
  • Requirements Managementunmatched
  • SAP ECC (fka SAP R/3 and SAP ERP)unmatched
  • SAP MMunmatched
  • SAP NetWeaver Process Integration (SAP PI)unmatched
  • SOAP (Simple Object Access Protocol)unmatched
  • Software Development Lifecycle (SDLC)unmatched
  • Supervisory Control and Data Acquisition (SCADA)unmatched
  • Supply Chainunmatched
  • System Integration (SI)unmatched
  • System Validationunmatched
  • Technical/Engineering Designunmatched
  • Time Managementunmatched
  • Vendor/Supplier Managementunmatched
  • Warehousingunmatched

Description

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?

Numbers & Facts

LocationFoster City, CA
IndustryManagement Consulting Services
Salary$16.50–$57.14 Per Hour
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttps://www.iconma.com/

Benefits

401K, Employee Referral Program, Life Insurance

About Company

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

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