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.
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