Senior Engineer-Soln. Architect

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 the Technology Organization:

Technology at Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise.

About the Business Function:

From molecule to market, Global Manufacturing plays an important role in every step along a product's lifecycle. Most of our customers never see the scientific and technical resources behind our medicines. But customers experience, every day, the performance of our high-quality products and global supply network.

Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products: Engineering; Manufacturing Information & Control Systems (); Quality & Labs, Technology Services/Manufacturing Science; Global Health, Safety and Environment; and Global Supply Chain.

Job Title:Senior Engineer / Solution Architect – Advanced Methodology Automation & Empower Configuration

The Senior Engineer / Architect will be responsible for the design, development, and deployment of analytical test methods for HPLC within the laboratory digital ecosystem. This includes configuring and managing Empower policies, integrating chromatography data with enterprise LIMS (e.g., LabVantage), and driving automation and standardization of analytical method lifecycles. This role ensures that analytical workflows are compliant, efficient, and aligned with global laboratory digitalization and data integrity standards.

Key Responsibilities:

Whatyou'llbe doing:

Analytical Method Design & Configuration:

• Lead the creation, configuration, and lifecycle management of HPLC test methods in LIMS and Empower.
• Define method parameters, specifications, and chromatographic conditions (column, solvent, gradient, detector, etc.).
• Establish method templates to enable automated or semi-automated method build and versioning.
• Ensure all method configurations adhere to cGMP, ALCOA+, and company data integrity standards.

Empower System Configuration & Policy Management:

• Configure and manage Empower project templates, instrument policies, and user privileges.
• Define naming conventions, acquisition methods, processing methods, and reporting templates for HPLC workflows.
• Proficiency in developing and validating Empower custom fields and calculation logic for assay, impurity, and system suitability workflows, including conditional formulas and summary calculations.
• Ability to troubleshoot calculation issues and integrate custom fields seamlessly with processing methods and report methods in a compliant GxP environment.
• Implement and maintain Empower policies for chromatographic data processing, result calculation, and electronic signatures.
• Partner with Quality and IT teams to ensure Empower configuration aligns with validated system procedures and regulatory requirements.

Integration & Automation:

• Capability to create global method templates and copy to local Empower instances as part of deployment.
• Collaborate with LIMS and integration teams to map and automate method data exchange between LabVantage (or other LIMS) and Empower.
• Develop or validate automated workflows for method build, data capture, and result transfer between systems.
• Contribute to the digital method management strategy, including automated test method creation, versioning, and approval workflows.

Technical Leadership & Governance

• Serve as the subject matter expert (SME) for HPLC method digitalization and Empower configuration.
• Establish best practices, templates, and governance standards for analytical method management across sites.
• Provide technical oversight for system changes, upgrades, and validation related to Empower or LIMS integrations.
• Mentor junior engineers and analysts on chromatography method lifecycle management and digital data flow.

Compliance & Validation

• Ensure all configurations and automation scripts are validated and maintained in compliance with GxP and 21 CFR Part 11.
• Develop and maintain validation documentation (URS, FS, test scripts, trace matrices) for Empower and method automation tools.
• Participate in internal and external audits related to analytical system data integrity and validation.

How you will succeed:

• Reduction in manual method configuration effort and errors.
• Consistent application of Empower and LIMS method templates across sites.
• Improved data integrity, audit readiness, and automation maturity.
• Faster onboarding of new or updated test methods.
• Ensuring compliance with global digital lab governance and validation standards.

What you should bring:

• Deep technical understanding of chromatographic method design and data management.
• Strong system configuration and integration skills (LIMS Empower).
• Analytical thinker who can translate lab method requirements into digital configurations.
• Strong collaboration and stakeholder engagement across Quality, IT, and Manufacturing functions

Basic Qualifications and Experience Requirement:

• Bachelor's or Master's degree in Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 12+ years of experience in a regulated pharmaceutical QC or R&D environment, with deep expertise in HPLC and chromatography data systems (Empower preferred).
• Strong experience configuring Empower policies, projects, and processing methods.
• Hands-on experience with LIMS (LabVantage preferred), including test method setup and data integration.
• Knowledge of method validation principles (ICH Q2) and analytical data workflows.
• Proven understanding of GxP, ALCOA+, Part 11, and data lifecycle management principles.
• Hands-on experience with JIRA, ALM, and ServiceNow (SNOW) for requirement tracking, defect management, and change control activities in regulated environments.

Additional Skills/Preferences:

• Experience with automation or integration tools (e.g., Talend, Boomi, Python, or Empower SDK).

Additional Information:N/A

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 ) 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.