Manufacturing IT Business Analyst

Catalyx • Foster City, CA

4d

About The Position

Catalyx is seeking a highly technical Manufacturing IT Business Analyst to support a large-scale MES and SAP transformation within a GMP-regulated manufacturing environment. This role sits at the intersection of business process design, IT/OT integration, and digital manufacturing systems, requiring deep expertise across MES, SAP, lab systems, and plant-floor data architecture.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field
• 5–10+ years of experience as a Business Analyst in manufacturing or life sciences environments
• Strong hands-on experience with Werum PAS-X MES and SAP EWM
• Experience with at least two of the following: LIMS (LabWare or Benchling), Veeva QMS/QDMS, OSI PI Historian, Maximo
• Deep understanding of GMP processes and regulatory requirements
• Proven experience with fit-gap analysis, requirements engineering, and process modeling
• Strong understanding of IT/OT integration and manufacturing data flows

Responsibilities

• Lead end-to-end requirements gathering, documentation, and validation across manufacturing and quality domains
• Perform fit-gap analysis to align current processes with future-state system capabilities
• Translate business needs into functional and technical specifications for MES, SAP, and integrated systems
• Ensure full traceability from requirements through design, testing, and deployment
• Analyze and optimize manufacturing processes in compliance with GMP standards
• Partner with Manufacturing, QA, QC, and Warehouse teams to improve workflows and ensure data integrity
• Support electronic batch records, workflow design, and exception handling
• Serve as SME across core platforms, including MES (Werum PAS-X), SAP EWM, LIMS (LabWare/Benchling), Veeva QMS/QDMS, OSI PI, and Maximo
• Define and support IT/OT integration architecture and system interoperability
• Collaborate on APIs, middleware, and end-to-end data flows across systems
• Design scalable data models and integration patterns for manufacturing and quality data
• Ensure alignment with enterprise data architecture and governance standards
• Support digital thread initiatives and data integrity practices (ALCOA+)
• Contribute to vendor selection, RFP development, and solution evaluation
• Provide functional and technical input during implementation and configuration
• Partner with vendors and system integrators to ensure solutions meet business requirements
• Act as liaison across Manufacturing, QA, QC, Warehouse, IT/OT, and Automation
• Facilitate workshops, design sessions, and stakeholder alignment
• Support change management, training, and user adoption

Benefits

• Total Rewards package
• Great personal benefits
• Professional growth opportunities
• Assistance with Critical Skills Visa applications for eligible candidates

What This Job Offers

• Job Type: Full-time
• Career Level: Senior