Overview
On Site
Full Time
Skills
Workflow
Root Cause Analysis
Collaboration
Pharmaceutical Industry
GMP
GxP
Regulatory Compliance
Enterprise Resource Planning
SAP
SQL
MES
Database
Programmable Logic Controller
SCADA
Documentation
Communication
IQ
OQ
PQ
Computerized System Validation
Pharmaceutics
Manufacturing
Job Details
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 :
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
- 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.
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