MES Technical Lead/ Project Manager

Job Title:MES Technical Lead / Project Manager (Hybrid Role)

Location:Foster City, CA (Onsite)

Tax Term (W2, C2C):W2

Job Type (Permanent/Contract):Contract

Duration:Long Term

Description:

We are seeking a hands-on MES Technical Lead / Project Manager with strong, proven experience in both Werum Client-X MES and Emerson DeltaV DCS integration to support a digital manufacturing program. This is a technically demanding, execution-focused role with approximately 70% hands-on technical work spanning Client-X configuration, EBR/MBR design, DeltaV-to-MES interface specification and testing, and GxP validation activities. The remaining 30% covers project coordination, including workstream scheduling, RAID log management, workshop facilitation, and status reporting.

Role and Responsibilities:

Technical Experience

• 5+ years of hands-on Werum Client-X experience in a GMP biopharma or pharma manufacturing environment with direct involvement in EBR/MBR configuration, recipe authoring, ISA-88 process modeling, and system go-live.
• 3+ years of hands-on DeltaV-to-MES integration experience, including designing or implementing OPC UA/DA tag mapping, phase trigger signal logic, CPP data capture specifications, and DeltaV-Client-X interface troubleshooting.
• Independently design, specify, test, and troubleshoot DeltaV-to-Client-X interfaces.
• Deliver GxP validation documentation including IQ/OQ/PQ protocols, RTM, URS/FRS, and validation summary reports under GAMP 5 and 21 CFR Part 11.
• Configure and troubleshoot OPC UA/DA communication, tag discovery, subscriptions, server configuration, and performance tuning.

Integration & Enterprise Systems

• Define MES integration requirements with enterprise applications such as SAP S/4HANA (PP/MM/EWM), LIMS, QMS/QDMS, and OSI PI Historian.
• Support MES-ERP integrations using IDocs, BAPI, REST APIs, production order lifecycle, goods movement, and batch/lot management.
• Author interface specifications, data flow diagrams, and tag mapping documents.

Project Management

• Manage MES/automation workstreams, schedules, RAID logs, and cross-functional coordination.
• Track technical deliverables, resolve blockers, and communicate project status.
• Facilitate technical workshops and maintain meeting minutes, decision logs, and action registers.

Required Skills:

• Werum Client-X MES.
• Emerson DeltaV.
• MES Technical Leadership.
• Project Management.
• Electronic Batch Records (EBR).
• Master Batch Records (MBR).
• ISA-88.
• OPC UA / OPC DA.
• DeltaV-Client-X Integration.
• GxP Validation.
• IQ / OQ / PQ.
• URS / FRS.
• RTM.
• GAMP 5.
• 21 CFR Part 11.
• SAP S/4HANA (PP/MM/EWM).
• LIMS (LabWare, Benchling, or equivalent).
• QMS / QDMS (Veeva Vault or equivalent).
• OSI PI Historian.
• REST APIs.
• IDocs.
• BAPI.
• Tag Mapping.
• Data Flow Diagrams.
• RAID Log Management.
• Technical Workshop Facilitation.

Qualifications:

• 5+ years of hands-on Werum Client-X implementation and configuration experience.
• 3+ years of hands-on DeltaV-to-MES integration experience.
• Experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing environments.
• Strong knowledge of GAMP 5, 21 CFR Part 11, and GxP validation practices.
• Experience integrating MES with SAP, LIMS, QMS, and Historian systems.
• 3 5 years of Project Management or Technical Lead experience on MES or Manufacturing IT projects.
• PMP/CAPM certification is a plus.
• 14+ years of overall experience.