Job Title

Junior Lab Systems Engineer

Role Overview

This role is for 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.

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.

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

Bachelors 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.