Jobs via Dice ยท 12 hours ago
MES Operations Analyst/Developer
United States
Full-time
Remote
Mid, Senior Level
$80/hr - $92/hr
4+ years expDice is the leading career destination for tech experts at every stage of their careers. The MES Operations Analyst/Developer is responsible for implementing and supporting the Manufacturing Execution System (MES) to enhance pharmaceutical manufacturing operations while ensuring compliance with regulatory standards. This role requires collaboration with various teams to optimize processes and maintain system performance.
Computer Software
Responsibilities
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
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
Qualification
Required
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
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
Company
Jobs via Dice
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0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase