Manufacturing Execution System (MES) Administartor

OpsTrakker MES

Job Summary

We are seeking an experienced MES (Manufacturing Execution System) Administrator to support the configuration, administration, validation, and day-to-day operation of the Manufacturing Execution System in a GMP-regulated manufacturing environment. The ideal candidate will be responsible for maintaining system performance, managing configurations, supporting validation activities, troubleshooting production issues, developing SOPs, and providing project administration support while ensuring compliance with FDA and GxP regulatory requirements.

Key Responsibilities

• Configure, administer, and maintain the Manufacturing Execution System (MES) to support manufacturing operations.
• Manage MES system configurations, master data, workflows, electronic batch records, user roles, and security settings.
• Perform system administration activities including user account management, access control, and periodic user access reviews.
• Support Computer System Validation (CSV/CSA) activities including Validation Plans, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports, and periodic reviews.
• Ensure MES maintains a validated state throughout system upgrades, patches, enhancements, and configuration changes.
• Troubleshoot MES application issues, identify root causes, and coordinate issue resolution with IT, Quality, Engineering, and vendor support teams.
• Develop, review, and maintain Standard Operating Procedures (SOPs), Work Instructions, User Guides, and system administration documentation.
• Support change control activities, impact assessments, deviation investigations, CAPAs, and system documentation updates.
• Execute system configuration testing, regression testing, User Acceptance Testing (UAT), and support production deployments.
• Monitor MES system health, performance, interfaces, and scheduled jobs to ensure high system availability.
• Coordinate integration testing between MES and enterprise systems such as SAP, LIMS, ERP, SCADA, and automation platforms.
• Support regulatory inspections and internal/external audits by providing validation documentation and compliance evidence.
• Maintain audit trails, electronic records, and electronic signatures in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Provide technical support and end-user training on MES functionality and standard operating procedures.
• Participate in MES implementation projects, system upgrades, and continuous improvement initiatives.
• Support project administration activities including project planning, status reporting, meeting coordination, document management, risk logs, action item tracking, and stakeholder communication.