MES Business Analyst
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Summary
A business analyst role at a GMP-regulated manufacturing site in Indianapolis (hybrid): elicit requirements from shop-floor, quality, warehouse, and supply-chain stakeholders, translate them into functional designs bridging MES, LIMS, and SAP ERP, run testing/UAT, and author GAMP 5 validation deliverables ensuring 21 CFR Part 11 and data integrity compliance.
MES Business Analyst
Location: Hybrid, Indianapolis, IN
Responsibilities
- Elicit and document business, functional, and non functional requirements from shop floor, manufacturing, quality, warehouse, and supply chain stakeholders
- Translate business and shop floor requirements into functional solution designs, balancing usability, compliance, and maintainability
- Develop process maps (as is / to be), user stories, data mapping specifications, and acceptance criteria
- Perform fit gap analysis between manual/paper processes and digital solutions, identify where low code solutions can close functional gaps between MES, LIMS, ERP, and other manual processes
- Author and execute test plans, test cases, and UAT scripts, drive defect resolution through to deployment
- Ensure solutions comply with GxP, GMP, 21 CFR Part 11, and data integrity (ALCOA+) requirements, author CSV/CSA validation deliverables (GAMP 5)
- Document technical designs, configuration standards, SOPs, and best practices
- Facilitate workshops, demos, and requirement walkthroughs with stakeholders from operators to senior leadership
- Continuously identify and deliver digitization and process improvement opportunities across the site
Requirements
Required Qualifications
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
- Working knowledge of manufacturing systems, MES, LIMS, ERP (SAP), including how these systems integrate at a functional level
- Strong understanding of GxP, GMP, 21 CFR Part 11, data integrity, and validation (GAMP 5)
- Ability to independently take a requirement from stakeholder conversation through design, test, validation, and deployment coordination
- Excellent communication and stakeholder management skills
Preferred Qualifications
- Experience at a greenfield facility startup or greenfield MES deployment
- Familiarity with warehouse/inventory and lab processes, cycle counts, receiving, bin to bin transfers, scrapping, shipping, sampling, and chain of custody handling
- Exposure to SAP MM/PP/QM and LIMS platforms (LabWare, LabVantage, or similar)
- Basic scripting/SQL and data analysis skills for troubleshooting and reporting
- Agile/Scrum experience