MES Business Analyst
Job Location:
Indianapolis, IN - USA
Monthly Salary:
Experience Required:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
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
