Senior Lab Systems Engineer – CDS and LES

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life\-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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.

Senior Lab Systems Engineer – CDS and LES

The Senior Lab Systems Engineer drives the implementation, configuration, and support of Laboratory Execution Systems (LES) — primarily SmartLab — with secondary responsibility for Lab applications \- Empower CDS (including LAC/E). The role ensures systems are compliant, scalable, and integrated with connected platforms such as LIMS, CDS, and enterprise systems. Strong candidates will bring broad experience across laboratory informatics (LIMS, CDS, ELN, or LES).

Key Responsibilities

• Deploy, configure, integrate, and support Empower/LAC/E and SmartLab LES, including interface development and instrument integrations.
• Plan releases and influence lifecycle/architecture decisions.
• Resolve incidents and problems; coordinate Tier 1 support; enable analytics via reports/dashboards.
• Establish user roles, privileges, and security models in accordance with global and site governance.

Automation \& Digital Integration

• Build automation to reduce manual effort in access provisioning, deployments, and release activities.
• Optimize SmartLab/LES and Empower application processes, including instrument integration and LAC/E build and release management.
• Design and implement integration solutions across LES, CDS, QMS, and Data Lake platforms using APIs and middleware.
• Support global LES (SmartLab/LabVantage) implementations and drive data enrichment activities.

Governance, Validation \& Compliance

• Ensure compliance with GMP principles including 21 CFR Part 11, Annex 11, ALCOA\+ data integrity, documentation, and change control.
• Maintain GxP/CSV compliance and documentation (develop/config specs, SOPs); support QA change control and periodic reviews.
• Complete CAPA/incident/change processes using ITIL practices; support access governance and role\-based provisioning.
• Team representation in audits and ensure all integrations and automation meet regulatory requirements.

Leadership \& Collaboration

• Serve as Technical SME for SmartLab, Lab Applications, leading end\-to\-end system lifecycle management and guiding vendor partner support teams and local IT staff.
• Partner with global quality, lab, and IT SMEs to define standards for method and site onboarding.
• Drive process improvements through automation, standard templates, and adoption of new technologies (AI/ML\-assisted method generation, smart drivers).

What You Should Bring

• Rich experience in applications \- Empower (Waters CDS), including LAC/E deployment, instrument integration, and chromatography data management.
• Experience with SmartLab LES and/or LabVantage LIMS — configuration, laboratory workflows.
• Deep understanding of GMP regulations: 21 CFR Part 11, Annex 11, ALCOA\+, and GxP compliance in pharma/biotech.
• Strong database and SQL knowledge; familiarity with Citrix and Oracle\-based environments.
• Experience in developing technical documents, SOPs, and knowledge articles.
• Ability to work across global teams (IT, Quality, Lab Operations).
• Hands\-on experience with JIRA, ALM, and ServiceNow.
• 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 related field with 8\+ years of experience.
• 6\+ years in laboratory informatics (pharma/biotech or chemical).
• 4\+ years hands\-on with Empower/LAC/E.
• Demonstrated experience in CSV/SDLC validation knowledge.
• Certification in any lab solution is a plus.

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 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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