MES Engineer

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 MESERP 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.