Net2Source (N2S) ยท 9 hours ago
Sr. Analyst - II*
United States
Full-time
Remote
Mid, Senior Level
$75/hr - $100/hr
4+ years expNet2Source Inc. is a global leader in workforce solutions, recognized for its rapid growth and innovative approach to connecting talent with opportunities. The MES Operations Analyst / Developer is responsible for implementing and supporting the Manufacturing Execution System (MES) to enhance pharmaceutical manufacturing operations, ensuring compliance and efficiency through collaboration with various teams.
B2BDeliveryHuman ResourcesInformation Technology
Responsibilities
Implement MES installations, upgrades, patches, and configuration changes across DEV, INT, and PROD environments
Configure and maintain Master Batch Records (MBRs), workflows, unit operations, parameters, formulas, and system objects in Client MES
Architect, model, test, and deploy MES solutions for new manufacturing processes and equipment integrations
Coordinate deployment of MES workstations, terminals, and peripherals in manufacturing areas
Ensure MES system performance, reliability, and compliance during steady-state operations and enhancement projects
Provide L2/L3/L4 application support including issue triage, root-cause analysis, and resolution
Support on-floor manufacturing operations, including on-call coverage for priority production issues
Monitor MES logs, batch processes, system jobs, and interfaces to proactively identify and resolve issues
Maintain system stability through environment health monitoring, user administration, and routine maintenance
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 compliance with 21 CFR Part 11, Annex 11, GAMP 5, GMP, and internal SOPs
Support internal and external regulatory audits and maintain audit-ready documentation
Partner with Manufacturing, Quality, Automation Engineering, and IT Infrastructure teams to deliver compliant MES solutions
Collaborate with Operations and Manufacturing Excellence teams to optimize workflows, improve batch cycle times, and enhance right-first-time performance
Deliver MES training to operators, supervisors, and super-users, including development of training materials
Support MES integrations with ERP systems (SAP/EBS), LIMS, Historians (OSIsoft PI), WMS, SCADA/PLC, and other enterprise systems
Troubleshoot interface errors and ensure reliable data exchange via REST/SOAP, message queues, OPC/OPC UA, and middleware services
Contribute to MES data management strategies including data mapping, integration requirements, and data-flow documentation
Identify and implement enhancements to MES workflows, modeling, user experience, training materials, and documentation
Analyze MES performance metrics and operational data to support continuous improvement initiatives
Recommend system enhancements to improve manufacturing efficiency, reduce deviations, and enhance usability
Perform additional duties as assigned based on business and operational needs
Responsibilities and priorities may evolve to support manufacturing operations, system initiatives, or organizational objectives
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
Experience with MES installation on Linux platforms including OCP/NKP (PASX, PASX2X, CUPS)
Strong experience with Client MES configuration including MBR authoring, workflows, parameters, activities, and eBR lifecycle management
Solid understanding of GMP manufacturing processes, batch records, deviations, CAPAs, and data integrity principles (ALCOA+)
Experience with system validation activities including IQ/OQ/PQ, requirements development, test execution, and traceability
Familiarity with MES integrations to ERP systems (SAP/EBS) and other manufacturing systems
Strong troubleshooting, analytical, and documentation skills in regulated environments
Working knowledge of Linux environments, Client MES infrastructure components, and container-based deployments
Ability to work independently, manage multiple priorities, and support off-hours or on-call requirements
Preferred
Experience migrating Client MES versions (e.g., 3.1.8 to 3.4.0)
Familiarity with SQL queries or scripting for analysis and troubleshooting within validation constraints
Experience with reporting and analytics tools such as Power BI, Tableau, or Spotfire
Participation in large-scale MES implementation or upgrade projects
Relevant certifications including Client MES, GAMP 5, ITIL, Lean Six Sigma, or equivalent
Company
Net2Source (N2S)
Net2Source (N2S) is a Minority owned global workforce solutions company recognized by SIA as the largest and fastest-growing Total Talent Solutions provider with a presence in 34 countries and in-house Glo-Cal (global and local) teams to support our clients.
1001-5000 employees
H1B Sponsorship
Net2Source (N2S) 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 (3)
2024 (7)
2022 (8)
2021 (10)
2020 (25)
Funding
Current Stage
Late StageLeadership Team
Ashish Garg
Founder & CEO
Company data provided by crunchbase