MES Business Analyst

RADcube • Indianapolis, IN

4d • Hybrid

About The Position

The MES Business Analyst will be responsible for eliciting and documenting business, functional, and non-functional requirements from various stakeholders across shop floor, manufacturing, quality, warehouse, and supply chain. This role involves translating these requirements into functional solution designs that prioritize usability, compliance, and maintainability. The analyst will develop process maps, user stories, data mapping specifications, and acceptance criteria. A key part of the role is performing fit-gap analysis between manual processes and digital solutions, identifying opportunities for low-code solutions to bridge functional gaps between MES, LIMS, ERP, and other systems. The position also requires authoring and executing test plans, test cases, and UAT scripts, driving defect resolution, and ensuring solutions comply with GxP, GMP, 21 CFR Part 11, and data integrity (ALCOA+) requirements. This includes authoring CSV/CSA validation deliverables (GAMP 5). The role involves documenting technical designs, configuration standards, SOPs, and best practices, as well as facilitating workshops, demos, and requirement walkthroughs with stakeholders at all levels. Continuous identification and delivery of digitization and process improvement opportunities across the site are expected.

Requirements

• 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

Nice To Haves

• 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

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

What This Job Offers

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