MES Business Analyst

RADcube - A NLogix Company • Indianapolis, IN

5d • Hybrid

About The Position

The MES Business Analyst will be responsible for eliciting and documenting business, functional, and non-functional requirements from various stakeholders in manufacturing, quality, warehouse, and supply chain. This role involves translating these requirements into functional solution designs, developing process maps, user stories, and data mapping specifications. The analyst will perform fit-gap analysis, author and execute test plans, and ensure solutions comply with GxP, GMP, 21 CFR Part 11, and data integrity requirements. Additionally, the role includes documenting technical designs, SOPs, and best practices, facilitating workshops, and identifying digitization and process improvement opportunities.

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