MES Engineer

Katalyst HealthCares and Life Sciences • Full-time • Indianapolis, IN, US • $85k - $110k / year • 3m ago

Job Summary :
We are seeking an experienced MES Engineer with strong Pharma domain experience to support and enhance Rockwell Automation Pharma Suite (Factory Talk Production Centre) in a regulated manufacturing environment. The ideal candidate must have hands-on experience working in GxP-compliant pharmaceutical manufacturing, supporting shop-floor systems, and ensuring compliance with regulatory standards.
Roles & Responsibilities :

Design, configure, implement, and support Rockwell PharmaSuite (FactoryTalk ProductionCentre)
Work closely with manufacturing, quality, validation, and automation teams in a pharma environment
Support batch manufacturing, electronic batch records (EBR), genealogy, traceability, and quality workflows
Ensure compliance with GMP, GxP, FDA 21 CFR Part 11 requirements
Integrate MES with ERP systems (SAP preferred) and automation systems (PLC/SCADA)
Troubleshoot MES production issues, perform root cause analysis, and support plant operations
Support system validation activities (IQ/OQ/PQ) and maintain required documentation
Participate in MES upgrades, enhancements, and rollout to new production lines
Provide Day-1 onsite support and collaborate with cross-functional teams

Education & Experience :

5+ years of experience as an MES Engineer in the pharmaceutical industry
Hands-on experience with Rockwell PharmaSuite / FactoryTalk ProductionCentre
Strong knowledge of Pharma manufacturing processes (Batch, Packaging, Weigh & Dispense)
Experience with GMP, GxP, FDA 21 CFR Part 11 compliance
Strong experience with MES-ERP integrations (SAP preferred)
Working knowledge of SQL and MES databases
Experience with PLC/SCADA integration (Rockwell Automation preferred)
Strong troubleshooting, documentation, and communication skills
Experience in Validation (IQ/OQ/PQ) and CSV
Exposure to ISA-95 standards
Prior experience in regulated pharma manufacturing plants.