Hybrid MES & Manufacturing Systems Analyst

RADcube; Indianapolis (IN); Hybrid; USD 90,000 - 120,000; Full time

Job summary

RADcube is seeking a MES Business Analyst to join our Indianapolis hybrid team. You will elicit and document requirements from shop floor and supply chain stakeholders, translate them into implementable designs, and drive validation and deployment in alignment with GMP and 21 CFR Part 11.

Key focus includes ensuring data integrity, mapping processes between MES, LIMS, ERP (SAP), and other systems, and delivering digitization opportunities across the site.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• Working knowledge of MES, LIMS, and ERP (SAP) integration.
• Strong understanding of GxP, GMP, 21 CFR Part 11 and data integrity.
• Ability to manage requirements from stakeholder to design, test, and deployment.
• Excellent communication and stakeholder management.

Responsibilities

• Elicit and document business, functional, and non-functional requirements from shop floor, manufacturing, quality, warehouse, and supply chain.
• Translate requirements into functional 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 MES, LIMS, ERP and other processes.
• Author tests, test plans, and UAT scripts, drive defect resolution through to deployment.
• Ensure solutions comply with GxP, GMP, 21 CFR Part 11, and data integrity (ALCOA+) requirements.
• 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.

Skills

Communication

Stakeholder management

Requirement analysis

SQL basics

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

SAP ERP

LIMS platforms

LabWare

LabVantage

Job description

RADcube is seeking a MES Business Analyst to join our Indianapolis hybrid team. You will elicit and document requirements from shop floor and supply chain stakeholders, translate them into implementable designs, and drive validation and deployment in alignment with GMP and 21 CFR Part 11.

Key focus includes ensuring data integrity, mapping processes between MES, LIMS, ERP (SAP), and other systems, and delivering digitization opportunities across the site.