Sr Lab Systems Engineer

Eli Lilly And Company; Hyderabad; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Eli Lilly And Company seeks a Senior Lab Systems Engineer to deliver and maintain laboratory applications across Manufacturing & Quality. The role supports NuGenesis SDMS and Empower CDS, enabling automation and data integrity across the Global Lab organization.

Responsibilities include system deployment, integrations, validation, CAPA, and SOP documentation. Mentoring junior staff and collaborating with cross-functional teams are essential parts of the role.

Qualifications

• Bachelors or equivalent in CS/Instrumentation/Chemical Engineering/Analytical Chemistry or related field.
• 15+ years of experience in laboratory informatics or CDS/SDMS support.
• Hands-on experience with NuGenesis SDMS and/or Empower CDS.
• Experience in GMP-regulated environments with data integrity and validation standards.
• Experience handling incidents and driving CAPA processes.
• Familiarity with CSV/SDLC practices.
• Certification on Lab or CDS Solution is a plus.

Responsibilities

• Support installation, deployment, and configuration of NuGenesis SDMS and Empower CDS with integrations.
• Deliver system integration and designs.
• Analyze, triage, and resolve incidents related to Lab Systems using ServiceNow/JIRA/ALM.
• Coordinate system validation activities including IQ/OQ/PQ protocols and validation docs.
• Support CAPA processes for CDS/SDMS incidents with root-cause documentation.
• Configure and maintain Labs system settings, user access, instrument methods, project structures.
• Collaborate to maintain SOPs, user docs, and knowledge articles.
• Mentor junior team members in architecture, development, deployment and troubleshooting.

Skills

NuGenesis SDMS

Empower CDS

System architecture

GMP compliance

Lab informatics

Data integrity

SQL

Jasper Reports

Crystal Reports

MuleSoft

Boomi

Talend

ServiceNow

JIRA

ALM

Education

Bachelor's in CS/Instrumentation/Chemical Eng/Analytical Chemistry

Tools

SQL

Jasper Reports

Crystal Reports

MuleSoft

Boomi

Talend

ServiceNow

JIRA

ALM

Job description

Role Overview

This role is for TEMAIL_ADDRESS 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.

Job Role: Senior Lab Systems Engineer

Key Responsibilities

• Support installation, deployment, and configuration of NuGenesis SDMS and Empower CDS systems, including integration with other systems and platforms
• Delivering systems integration and designs
• 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.
• Mentoring Junior team members in architecture designs, system development, deployment and troubleshooting

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

• Good experience or strong working knowledge of NuGenesis SDMS and/or Empower CDS - support and deployment experience across either or both platforms is needed.
• Experienced developing system architecture with scalability and maintenance
• 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

• Bachelors or equivalent degree in Computer Science/Instrumentation/Chemical Engineering/Analytical Chemistry, or a related field.
• 15+ 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, and other Labs systems 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