Senior Lab 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: Senior Lab Systems Engineer 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 · 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 acti