MES Business Analyst

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

• Bachelors 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
  

Required Skills:

Required Qualifications Bachelors 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

Required Education:

Bachelors Degree