Manufacturing IT Business Analyst

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

Key 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

·       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

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.