MES Technical Lead/ Project Manager

Job Title:MES Technical Lead / Project Manager

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 expertise in Werum Client-X MES and Emerson DeltaV to support a digital manufacturing program in a GMP-regulated biopharmaceutical environment. This hybrid role combines hands-on MES technical execution with project management responsibilities, including Client-X configuration, DeltaV integration, GxP validation, workstream coordination, and stakeholder management.

Role and Responsibilities:

• Lead hands-on MES implementation activities using Werum Client-X, including EBR/MBR configuration, recipe authoring, ISA-88 process modeling, and system go-live support.
• Design, implement, test, and troubleshoot DeltaV-to-Client-X integrations, including OPC UA/DA tag mapping, phase trigger logic, and CPP data capture.
• Develop interface specifications, tag mapping documents, and data flow diagrams for MES integrations.
• Support GxP validation activities including IQ/OQ/PQ protocols, URS, FRS, RTM, and validation summary reports in compliance with GAMP 5 and 21 CFR Part 11.
• Define and support MES integrations with enterprise systems such as SAP S/4HANA, LIMS, QMS/QDMS, and OSI PI Historian.
• Coordinate project workstreams, manage schedules, RAID logs, risks, and cross-functional dependencies.
• Facilitate technical workshops, document meeting minutes, maintain decision logs, and provide regular project status updates.
• Work independently to manage technical deliverables while collaborating with manufacturing, automation, quality, and IT teams.

Required Skills:

• Werum Client-X MES
• Emerson DeltaV
• Project Management
• EBR/MBR Configuration
• ISA-88
• OPC UA/DA
• GxP Validation (IQ/OQ/PQ)
• GAMP 5
• 21 CFR Part 11
• SAP S/4HANA Integration
• LIMS
• OSI PI Historian

Qualifications:

• 14+ years of experience in MES, manufacturing IT, or automation.
• 5+ years of hands-on Werum Client-X implementation and configuration experience.
• 3+ years of hands-on DeltaV-to-MES integration experience.
• Strong knowledge of OPC UA/DA standards and real-time manufacturing integration.
• Experience delivering GxP validation documentation in FDA-regulated environments.
• Experience integrating MES with enterprise applications such as SAP, LIMS, QMS, and Historian systems.
• 3 5 years of project management or technical leadership experience.
• PMP or CAPM certification is a plus.