MES Business Analyst

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