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Ecocareers · 2 weeks ago

MES Engineer

Indianapolis, IN

Full-time

Onsite

Senior Level

5+ years exp

Confidential company is seeking an experienced MES Engineer with strong Pharma domain experience to support and enhance Rockwell Automation Pharma Suite in a regulated manufacturing environment. The ideal candidate will work closely with manufacturing, quality, validation, and automation teams to ensure compliance with regulatory standards and support batch manufacturing processes.

Staffing & Recruiting

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

Qualification

Rockwell PharmaSuitePharma domain experienceGMP/GxP complianceMES-ERP integrationSQLPLC/SCADA integrationTroubleshootingValidation (IQ/OQ/PQ)ISA-95 standardsDocumentationCommunication skills