MES Operations Analyst​/Developer

Remote Position

The MES Operations Analyst/Developer is responsible for implementing, configuring, supporting, and enhancing the Manufacturing Execution System (MES) to enable compliant and efficient pharmaceutical/biotech manufacturing operations. This role supports Client-X MES installation, upgrades, configuration, testing, and troubleshooting, and works closely with Manufacturing, Quality, Automation, and IT teams to understand process requirements, optimize electronic batch records (eBRs), and ensure GMP-compliant operation. The Analyst maintains deep system and business knowledge and drives continuous improvements across the MES ecosystem.

• Implement MES installations, upgrades, patches, and configuration changes across DEV/INT/PROD environments.
• Configure and maintain Master Batch Records (MBRs), workflows, unit operations, parameters, formulas, and system objects in Client-X.
• Architect, model, test, and deploy MES solutions for new manufacturing processes or equipment integrations.
• Plan, prepare, and coordinate deployment of MES workstations, terminals, and peripherals in manufacturing areas.
• Ensure MES system performance, reliability, and compliance during ongoing operations and enhancement projects.

• Provide L2/L3/L4 support including issue triage, root‑cause analysis, and resolution of MES application incidents.
• Support on‑floor manufacturing operations during production, including on‑call coverage for priority issues.
• Monitor MES logs, batch processes, system jobs, and interfaces to proactively identify and resolve system problems.
• Maintain system stability by managing environment health, user administration, and routine maintenance tasks.

• Develop and maintain MES documentation including URS, FRS, design specifications, test scripts, traceability matrices, and validation reports.
• Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA+) evaluations, and change control activities.
• Ensure adherence to 21 CFR Part 11, Annex 11, GAMP 5, GMP, and internal SOPs.
• Support internal and external regulatory audits and maintain audit‑ready documentation.

• Work closely with Manufacturing, Quality, Automation Engineering, and IT Infrastructure to deliver MES solutions aligned with business and compliance requirements.
• Collaborate with Operations and Manufacturing Excellence to evaluate process issues, implement system optimizations, and improve batch cycle times and right‑first‑time performance.
• Provide MES training to operators, supervisors, and super‑users, including creation of supporting materials.

• Support MES interfaces and integrations with ERP systems (SAP/EBS), LIMS, Historians (OSIsoft PI), WMS, SCADA/PLC, and other enterprise applications.
• Troubleshoot interface errors and ensure reliable data exchange via REST/SOAP, message queues, OPC/OPC UA, and middleware services.
• Contribute to MES data management strategy including data mapping, integration requirements, and data‑flow documentation.

• Identify opportunities to enhance MES workflows, modeling, user experience, training materials, and documentation.
• Analyze MES performance metrics and operational data to support continuous improvement initiatives.
• Recommend and implement enhancements to optimize manufacturing efficiency, reduce deviations, and improve system usability.

• Bachelor’s degree in Engineering, Information Systems, Industrial Engineering, Computer Science, or related technical discipline.
• 4+ years of hands‑on experience configuring, deploying, and supporting MES systems in a GMP-regulated pharmaceutical or biotech environment.
• MES installation in Linux technology OCP/NKP (PASX, PASX2X, CUPS).
• Strong experience configuring Client-X (M  authoring, workflows, parameters, activities, and e  lifecycle).
• Understanding of GMP manufacturing processes, batch records, deviations, CAPAs, and data integrity (ALCOA+).
• Experience with system validation including IQ/OQ/PQ, requirements development, test execution,…