MES Engineer

Indianapolis, IN, US • Posted 60+ days ago • Updated 8 hours ago

Full Time

On-site

Fitment

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Job Details

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

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: e6353499c46a79e60b822fd1bcaff0b
Posted 30+ days ago

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