MES Support Engineer
Job Title- MES Support Engineer
Location- Indianapolis / Charlotte
Salary Range- 65k to 70k
Role: The MES (Manufacturing Execution System) Support Engineer is responsible for providing technical support for MES applications used in manufacturing operations. The role ensures reliable system performance, rapid incident resolution, regulatory compliance, and continuous improvement of manufacturing execution processes. The engineer works closely with Production, Quality, Automation, IT, and Business teams to support day-to-day operations and site deployments. This role also required to available in person and flexible to work in a 24/7 rotating shift environment.
Key Responsibilities:
• Production Support & Incident Management
o Provide Tier-1,2/Tier-3 support for MES applications and manufacturing operations.
o Respond to and resolve incidents, service requests, and problem tickets through ServiceNow or designated support channels.
o Perform root cause analysis (RCA) and implement corrective actions to minimize recurring issues.
o Support on-call activities and critical production incidents to ensure minimal manufacturing disruption
• MES Configuration & Maintenance
o Maintain MES master data, workflows, recipes, electronic batch records (eBRs), equipment mappings, and system configurations.
o Support deployment of system enhancements, patches, and releases.
o Assist in change management activities, impact assessments, regression testing, and controlled deployments
• Manufacturing Operations Support
o Monitor MES performance and ensure successful batch execution and production processing.
o Troubleshoot issues related to equipment integration, material handling, process execution, and interfaces.
o Collaborate with shop-floor users to ensure smooth operation of manufacturing processes
• Validation & Compliance
o Ensure compliance with GMP, GxP, 21 CFR Part 11, and company quality procedures.
o Maintain audit readiness by supporting documentation, traceability, and electronic records management.
• Cross-Functional Collaboration
o Work closely with Manufacturing, QA, Automation, CSV, IT, and Digital teams.
o Participate in requirement gathering, solution design reviews, and process improvement initiatives.
o Support global rollouts, site onboarding, and knowledge transfer activities.
• Continuous Improvement
o Analyze process gaps and propose value improvement ideas.
o Support global standardization of MES processes and documentation.
Qualification and Specialization:
Industrial Engineering undergraduate degree. Any internships or projects done with PharmaSuite, Syncade, DeltaV MES, Opcenter, Camstar, Tulip, or similar MES applications.
Unique Experience from this Role:
Unique Experience Gained as a MES Support Engineer role provides a blend of technical expertise, regulatory knowledge, and cross functional collaboration. Some key unique experiences include:
• Real-Time Production Support Experience
o Support manufacturing sites across multiple geographies and time zones.
o Master high-pressure MES production support, troubleshooting real-time manufacturing issues and managing critical incidents in a 24x7 global environment. Develop rapid problem-solving skills, strong root cause analysis capabilities, and the ability to maintain uninterrupted pharmaceutical manufacturing operations.
• Deep MES Functional Knowledge
o Develop expertise in MES workflows, recipe execution, electronic batch records (eBRs), exception handling, and batch release processes.
o Gain hands-on experience supporting complex manufacturing execution environments.
• Regulated Pharma Manufacturing Experience
o Work within highly regulated GMP/GxP environments. This experience is rare and highly specialized, as only regulated industries require this level of MES expertise.
o Build knowledge of FDA 21 CFR Part 11 compliance, audit trails, electronic signatures, and validation requirements.
• Automation and System Integration Expertise
o Gain experience troubleshooting integrations between MES, PLCs, SCADA, DeltaV, SAP, LIMS, and Historian systems.
o Understand end-to-end manufacturing data flows from shop floor to enterprise systems.
• Validation and Quality Systems Experience
o Participate in IQ/OQ/PQ, UAT, regression testing, and release validation activities.
o Strengthen knowledge of Computer System Validation (CSV) and quality processes.
• Cross-Functional Collaboration
o Partner with Manufacturing, Quality, Automation, IT, Engineering, and Digital teams.
o Build stakeholder management and communication skills in a complex enterprise environment.
• Multi-Site Deployment & Digital Transformation
o Support MES rollouts, site onboarding, hyper care, and continuous improvement initiatives.
o Contribute to global digital manufacturing transformation programs.
Learning outcomes for the Trainee:
The selected Industrial Engineer Trainee will receive comprehensive, in person, on the job training to develop into a fully independent MES Support Engineer. Following completion of the training program, the trainee will be assigned to one of our U.S. manufacturing sites located in Indiana, North Carolina, or Wisconsin.