Senior Engineer-Soln. Architect - Advanced Methodology Automation & Empower Configuration at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, ManufacturingIndustries

Requirements

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
Expertise in configuring and managing Empower project templates, instrument policies, user privileges, naming conventions, acquisition methods, processing methods, and reporting templates for HPLC workflows
Knowledge of HPLC method parameters, specifications, and chromatographic conditions (column, solvent, gradient, detector, etc.)
Understanding of cGMP, ALCOA+, company data integrity standards, and regulatory requirements for validated systems
Experience integrating chromatography data with enterprise LIMS (e.g., LabVantage)

Responsibilities

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
Configure and manage Empower project templates, instrument policies, and user privileges
Define naming conventions, acquisition methods, processing methods, and reporting templates for HPLC workflows
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
Design, develop, and deploy analytical test methods for HPLC within the laboratory digital ecosystem
Configure and manage Empower policies, integrate chromatography data with enterprise LIMS (e.g., LabVantage), and drive automation and standardization of analytical method lifecycles
Ensure analytical workflows are compliant, efficient, and aligned with global laboratory digitalization and data integrity standards

Skills

Key technologies and capabilities for this role

Solution ArchitectureAutomationConfiguration ManagementAdvanced MethodologiesManufacturing SystemsEngineering

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working in an office?

This information is not specified in the job description.

What are the key responsibilities and skills needed for this Senior Engineer / Solution Architect role?

The role involves designing, developing, and deploying analytical test methods for HPLC, configuring and managing Empower policies, integrating chromatography data with LIMS like LabVantage, and driving automation and standardization of analytical method lifecycles.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, hires diverse technology professionals, and focuses on innovative solutions to advance creating medicines that improve lives.

What makes a strong candidate for this Senior Engineer / Solution Architect position?

Strong candidates will have expertise in analytical method design and configuration for HPLC in LIMS and Empower, including defining method parameters, chromatographic conditions, establishing templates for automation, and ensuring compliance with data integrity standards.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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