Labs Systems Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About Lilly At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly. About Technology@Lilly At Lilly, technology is not a support function. It is how a global medicine company operates, innovates, and delivers. Lilly in Hyderabad builds the capabilities that make this possible, cloud platforms, AI systems, and automation at enterprise scale, all in service of a purpose that makes this technology work genuinely distinctive, from advancing drug discovery to enabling connected clinical trials to keeping a global medicine company running at the standard patients deserve. About the Business Function The Global Manufacturing & Quality Labs – Lab Systems team delivers and sustains lab informatics platforms enabling GMP-compliant laboratory operations across Lilly's global manufacturing network. We build, implement, and support coordinated digital lab solutions that ensure data integrity, regulatory compliance, and efficient analytical and quality control processes. Job Role: Labs Systems Engineer Role Overview This role is for Technology@Lilly MQ, responsible for driving, delivering and maintaining MODA and other applications that support laboratory execution and operations across the Manufacturing & Quality organization. This role will play a key supporting role within the Global Lab organization by assisting in the implementation, integration, configuration, and support of laboratory systems—primarily Environmental monitoring system - MODA—under the supervision of senior team members. This role focuses on supporting system operations, integrations, and validation activities, while enabling automation and digital initiatives that improve laboratory efficiency and data integrity. Key Responsibilities Drive the configuration, deployment, maintenance, and operations of MODA Environmental Monitoring systems across Manufacturing & Quality laboratories. Configure, maintain, and troubleshoot integrations between MODA and laboratory, manufacturing, and enterprise platforms including LabVantage LIMS, Empower CDS, SAP, MES platforms (PMX, PharmaSuite, Syncade), and middleware solutions. Develops & supports data interfaces, APIs, message-based integrations, and automated workflows to enable compliant sample lifecycle management, environmental monitoring, and results reporting. Assist in configuring and maintaining MODA system settings, user access, workflows, monitoring plans, sampling schedules, work item mappings, and data management processes. Collaborate with Quality, Laboratory Operations, Manufacturing, Engineering, vendors, and IT teams to support reliable and compliant laboratory and environmental monitoring operations. Execute integration of laboratory instruments, monitoring devices, data acquisition systems, and related informatics platforms with MODA and connected systems. Drive integration testing, interface validation, deployment, and release activities, ensuring successful implementation of new capabilities and enhancements. Contribute to the preparation and maintenance of SOPs, work instructions, system design documents, interface specifications, validation records, and knowledge management artifacts. Analyze, triage, troubleshoot, and resolve application, integration, and data-related incidents, service requests, and system issues using tools such as ServiceNow, JIRA, and ALM. Develop and execution of MODA Test scripts and IVI execution Developing and maintaining validation documents writing (e.g. validation artifacts, SOP, IVI, Test Scripts, etc.) Support CSV/CSA validation activities, including requirements traceability, risk assessments, protocol execution (IQ/OQ/PQ). Support CAPA, deviation, audit, and change management activities by investigating issues, documenting root causes, implementing corrective actions, and maintaining closure evidence. Monitor system and interface performance, identify improvement opportunities, and support automation and digital initiatives that enhance laboratory efficiency, data integrity, and regulatory compliance. Automation & Digital Integration Drive workflow automation and digitalization initiatives within MODA to improve operational efficiency, data integrity, and regulatory compliance. Develop and execute reporting, analytics, and data visualization capabilities to enable trend analysis, compliance monitoring, and business insights. Evaluate and implement integration and automation solutions leveraging APIs, middleware, and enterprise platforms to enhance system interoperability and user experience. Governance, Validation & Compliance Implement validation including writing and running test scripts, protocols, and maintaining all supporting validation documentation. Ensure all activities are performed and documented in strict compliance with GMP regulations, including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles. Support CAPA management for MODA system-related incidents, ensuring detailed documentation. Maintain GMP/GxP/CSV compliance documentation including build specs, configuration specs, and SOPs. Team representation in change control activities and periodic system review processes. Leadership & Collaboration Work with senior analysts, lab teams, QA, and IT SMEs to support day-to-day operations of MODA-EM system. Follow established standards, templates, and procedures defined global governance frameworks. Develop Lab system knowledge base through documentation updates, knowledge articles, and SOP revisions. What You Should Bring Good experience with MODA Environmental Monitoring systems, including system administration, integration, configuration, deployment, support, upgrades and lifecycle management. Experience supporting environmental monitoring workflows, including viable and non-viable monitoring, personnel monitoring, utilities monitoring, sample scheduling, incubation, trending, investigations, and reporting activities. Knowledge of MODA IT architecture (servers, interfaces, log files, etc.) Strong understanding of GMP, GxP, 21 CFR Part 11, Annex 11, CSV/CSA, and ALCOA+ principles within regulated pharmaceutical laboratory and manufacturing environments. Experience configuring, supporting, or troubleshooting integrations between MO