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.
