Junior Lab Systems Engineer

Eli Lilly and Company; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Lilly in Hyderabad: The Global Manufacturing & Quality Labs – Lab Systems team delivers and sustains lab informatics platforms for GMP operations. This role supports NuGenesis SDMS and Empower CDS, focusing on system operations, validation, and automation to improve data integrity.

You will collaborate with cross-functional teams to ensure compliant lab processes, documentation, and effective ICT governance within a fast-paced pharma environment.

Qualifications

• Hands-on experience with NuGenesis SDMS and/or Empower CDS in a GMP-regulated environment.
• Experience performing system validation (CSV/SDLC) in pharma/biotech.
• Experience driving CAPA processes and maintaining data integrity.

Responsibilities

• Install, deploy, and configure NuGenesis SDMS and Empower CDS; integrate with other platforms.
• Analyze, triage, and resolve lab systems incidents using ServiceNow, JIRA, or ALM.
• Coordinate IQ/OQ/PQ protocols and validation documentation.
• Support CAPA activities and maintain SOPs and user documentation.

Skills

NuGenesis SDMS

Empower CDS

GMP/data integrity

CAPA processes

Validation activities

SQL basics

LIMS familiarity

Education

Bachelor's degree in a related field

Tools

NuGenesis SDMS

Empower CDS

LabVantage/LIMS

SQL

Job description

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— 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.

Role Overview

This role is for Technology@Lilly MQ, responsible for delivering and maintaining applications that support laboratory operations across the Manufacturing & Quality organization. This role will play a key supporting role within the Global Lab organization by assisting in the implementation, configuration, and support of laboratory systems—primarily NuGenesis SDMS/ELN and Empower CDS—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

• Support installation, deployment, and configuration of NuGenesis SDMS and Empower CDS systems, including integration with other systems and platforms
• Analyze, triage and resolve incidents related to Lab Systems with tools like - ServiceNow, JIRA, or ALM.
• Coordinating system validation activities including preparation and execution of IQ/OQ/PQ protocols, test scripts, and validation documentation.
• Support CAPA processes for CDS/SDMS-related incidents, with documentation of root cause, corrective actions and working towards closure.
• Joining in configuring and maintaining Labs system settings, user access, instrument methods, and project structures.
• Collaborate with multi-functional teams to support system operations.
• to the preparation and maintenance of SOPs, user documentation, and knowledge articles.

Automation & Digital Integration

• Assist in configuring instrument integrations for chromatography systems connected to Empower, ensuring accurate data acquisition and transfer.
• Enabling integration tasks across CDS/SDMS/LIMS systems using defined configurations and middleware setups.
• Assist with LAC/E instrumentation support and systems project/method configurations as per requirement.

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 NuGenesis and Empower-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 NuGenesis and Empower systems.
• 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

• Hands-on experience or strong working knowledge of NuGenesis SDMS and/or Empower CDS — support and deployment experience across either or both platforms is needed.
• Good understanding and practical application of GMP regulations, including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles in a pharmaceutical or biotech environment.
• Experience supporting deployment and installation activities for NuGenesis SDMS or Empower CDS.
• Experience analysing and resolving incidents for lab systems
• Practical experience performing system validation activities in a GMP-regulated environment.
• Experience supporting CAPA processes, including documentation and corrective action follow-through.
• Familiarity with chromatography instrument integrations and Empower project/method configuration.
• Ability to write and maintain user documentation and SOPs
• Good communication and analytical skills
• Exposure to LabVantage LIMS or SmartLab platforms.
• Familiarity with other LIMS or lab informatics platforms (e.g.,LabWare, Star LIMS Darwin LIMS).
• Basic SQL and database knowledge for data integrity queries and system support.
• Knowledge of reporting technologies such as Jasper Reports or Crystal Reports.
• Basic understanding of ETL/middleware tools (MuleSoft, Boomi, Talend).
• Exposure to data analytics or digital lab transformation projects.

Basic Qualifications

• Bachelor's or equivalent degree in Computer Science/Instrumentation/Chemical Engineering/Analytical Chemistry, or a related field.
• Minimum 3 years of experience in laboratory informatics or CDS/SDMS support, preferably in the pharma, biotech, or chemicals industry.
• Hands-on experience with NuGenesis SDMS and/or Empower CDS deployment and support.
• 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 is an EEO/Affirmative Action Employer and 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.

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.