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 MODA and laboratory, manufacturing, or enterprise systems such as LabVantage LIMS, Empower CDS, SAP, MES platforms (PMX, PharmaSuite, Syncade), and middleware solutions.

Knowledge of system interfaces, APIs, middleware technologies, data flows, and integration concepts used to support automated laboratory and environmental monitoring processes.

Experience supporting validation and compliance activities, including risk assessments, traceability, protocol execution, defect management, and validation documentation.

Ability to analyze, triage, troubleshoot, and resolve application, integration, and data-related issues using tools such as ServiceNow, JIRA, ALM, or equivalent platforms.

Working knowledge of SQL, databases, reporting tools, and data analytics platforms to support troubleshooting, reporting, and operational insights.

Experience supporting laboratory instruments, monitoring devices, and data acquisition systems in regulated environments.

Strong analytical, communication, stakeholder management, and problem-solving skills with the ability to collaborate effectively across Quality, Manufacturing, Laboratory Operations, Engineering, and IT organizations.

Exposure to digital transformation, workflow automation, data integration, reporting, dashboarding, or process optimization initiatives within laboratory or manufacturing environments.

Ability to learn and adapt other Labs systems

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) supporting laboratory and manufacturing systems.

Exposure to cloud, automation, scripting, or AI-driven laboratory solutions.

Basic Qualifications

Bachelor's or equivalent degree in Computer Science/Instrumentation/Chemical Engineering/Analytical Chemistry, or a related field.

8+ years of experience supporting laboratory informatics applications in a GMP-regulated environment.

Knowledge of MODA IT architecture (servers, interfaces, log files, etc. and integration with other systems

Good experience in GMP-regulated environments with understanding of compliance, data integrity, and validation standards.

Experience in handling incidents and driving CAPA processes in a regulated lab environment.

Familiarity with system validation (CSV/SDLC) practices.

Good to have certification on any Lab or CDS Solution

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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