Job Title: MES Operation Developer
Location: Remote:
Job Summary
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 PAS‑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.
Key Responsibilities
MES System Implementation & Configuration
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 PAS‑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.
MES Support & Troubleshooting
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.
Validation, Documentation, & Compliance
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.
Cross‑Functional Collaboration
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.
Integrations & Data Management
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.
Continuous Improvement
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.
Required Qualifications
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 PAS‑X (MBR authoring, workflows, parameters, activities, and eBR 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, and traceability.
Familiarity with integrations between MES and ERP (SAP/EBS) or other manufacturing systems.
Strong troubleshooting, analytical, and documentation capabilities in a regulated environment.
Competence with Linux environment basics, PAS‑X infrastructure components, and container-based deployments (OCP/NKP).
Ability to work independently, manage multiple priorities, and support off-hours or on-call requirements.
Preferred Qualifications
Experience migrating PAS‑X versions (e.g., 3.1.8 to 3.4.0).
Familiarity with SQL queries or scripting for analysis or troubleshooting (within validation boundaries).
Experience with reporting/analytics tools (Power BI, Tableau, Spotfire, or similar platforms).
Participation in large-scale MES implementation or upgrade projects.
Certifications such as PAS‑X, GAMP 5, ITIL, Lean Six Sigma, or equivalent.
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