Ecocareers · 1 month ago
MES Engineer
Indianapolis, IN
Full-time
Onsite
Senior Level
5+ years expConfidential 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 must have hands-on experience working in GxP-compliant pharmaceutical manufacturing, supporting shop-floor systems, and ensuring compliance with regulatory standards.
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
Required
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
Preferred
SAP preferred
Rockwell Automation preferred
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase