Integrated Resources, Inc ( IRI ) · 17 hours ago
MES Operations Analyst/Developer
United States
Contract
Remote
Mid Level
$95/hr - $98/hr
4+ years expIntegrated Resources, Inc (IRI) is seeking an MES Operations Analyst/Developer responsible for implementing and enhancing the Manufacturing Execution System (MES) to support pharmaceutical and biotech manufacturing operations. The role involves collaboration with various teams to optimize electronic batch records and ensure compliance while providing support and troubleshooting for MES applications.
BiotechnologyHealth CareHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Shivi Singh
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 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 environmental health, user administration, and routine maintenance tasks
Develop and maintain MES documentation including URS, Client, 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 Client‐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, Client‐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 Client‐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 Client‐X, GAMP 5, ITIL, Lean Six Sigma, or equivalent
Company
Integrated Resources, Inc ( IRI )
Integrated Resources Inc.
501-1000 employees
H1B Sponsorship
Integrated Resources, Inc ( IRI ) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (5)
2023 (13)
2022 (9)
2021 (25)
2020 (39)
Funding
Current Stage
Late StageRecent News
2025-06-11
2025-06-11
2025-04-14
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