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Eli Lilly is seeking a Labs Systems Engineer to support the Global Manufacturing & Quality Labs team in Hyderabad. This role is responsible for driving, delivering, and maintaining MODA (environmental monitoring system) and related laboratory informatics platforms that enable GMP-compliant laboratory operations across Lilly's global manufacturing network.
Key responsibilities include:
- Configure, deploy, maintain, and operate MODA Environmental Monitoring systems across Manufacturing & Quality laboratories
- Configure and troubleshoot integrations between MODA and laboratory, manufacturing, and enterprise platforms including LabVantage LIMS, Empower CDS, SAP, and MES platforms (PMX, PharmaSuite, Syncade)
- Develop and support data interfaces, APIs, message-based integrations, and automated workflows for compliant sample lifecycle management and environmental monitoring
- Assist in configuring MODA system settings, user access, workflows, monitoring plans, sampling schedules, and data management processes
- Collaborate with Quality, Laboratory Operations, Manufacturing, Engineering, vendors, and IT teams to support reliable and compliant laboratory operations
- Execute integration testing, interface validation, deployment, and release activities
- Prepare and maintain SOPs, work instructions, system design documents, interface specifications, and validation records
- Analyze, triage, troubleshoot, and resolve application, integration, and data-related incidents using ServiceNow, JIRA, and ALM
- Develop and execute MODA test scripts and IVI (Installation Verification Installation) execution
- Support CSV/CSA validation activities, including requirements traceability, risk assessments, and protocol execution (IQ/OQ/PQ)
- Support CAPA, deviation, audit, and change management activities
- Monitor system and interface performance and identify improvement opportunities
- Drive workflow automation and digitalization initiatives within MODA
- Develop reporting, analytics, and data visualization capabilities for trend analysis and compliance monitoring
- Ensure all activities comply with GMP regulations, including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles
Requirements:
- Bachelor's degree or equivalent in Computer Science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field
- 8+ years of experience supporting laboratory informatics applications in a GMP-regulated environment
- Good experience with MODA Environmental Monitoring systems, including system administration, integration, configuration, deployment, support, upgrades, and lifecycle management
- Experience supporting environmental monitoring workflows (viable and non-viable monitoring, personnel monitoring, utilities monitoring, sample scheduling, incubation, trending, investigations, reporting)
- Knowledge of MODA IT architecture (servers, interfaces, log files)
- Strong understanding of GMP, GxP, 21 CFR Part 11, Annex 11, CSV/CSA, and ALCOA+ principles
- Experience configuring, supporting, or troubleshooting integrations between MODA and laboratory/manufacturing/enterprise systems
- Knowledge of system interfaces, APIs, middleware technologies, data flows, and integration concepts
- Experience supporting validation and compliance activities (risk assessments, traceability, protocol execution, defect management, validation documentation)
- Ability to analyze, triage, troubleshoot, and resolve application, integration, and data-related issues using ServiceNow, JIRA, ALM, or equivalent
- Working knowledge of SQL, databases, reporting tools, and data analytics platforms
- Experience supporting laboratory instruments, monitoring devices, and data acquisition systems in regulated environments
- Strong analytical, communication, stakeholder management, and problem-solving skills
- Exposure to digital transformation, workflow automation, data integration, reporting, dashboarding, or process optimization initiatives
- Ability to learn and adapt to other lab systems
- Familiarity with system validation (CSV/SDLC) practices
- Experience handling incidents and driving CAPA processes in regulated lab environments
Nice to have:
- Experience with LabVantage, SmartLab, LabWare, STARLIMS, Empower, Darwin LIMS, or other laboratory informatics platforms
- Experience with reporting tools (Power BI, SSRS, Jasper Reports) and integration technologies (MuleSoft, REST APIs, web services)
- Exposure to cloud, automation, scripting, or AI-driven laboratory solutions
- Certification on any Lab or CDS Solution
