Senior Engineer – Digital CMC PLM 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

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

(Not explicitly listed in the job description)

Responsibilities

Lead collaboration with cross-functional SMEs from Technical Services/Manufacturing Science (TSMS), Quality Assurance (QA), and Process Development (PD) to define and implement digital product control strategies within the PLM ecosystem
Oversee and approve data transfer protocol design and execution, ensuring alignment with global CMC standards and regulatory expectations
Drive configuration and governance of digital PLM systems (e.g., QbDVision), managing data structures, metadata standards, controlled vocabularies, and version control frameworks to ensure accuracy and compliance
Resolve complex data and process discrepancies during production data transfers through deep technical analysis and cross-team coordination
Establish and enforce data validation and verification frameworks to uphold data integrity and traceability throughout the product lifecycle
Provide expert oversight for critical system build tasks, including data migration, integration, and controlled document updates
Architect and optimize integration between manufacturing digital platforms such as LIMS, MES, and ERP systems to enable seamless data flow and interoperability
Champion compliance and documentation excellence, ensuring adherence to Good Documentation Practices (GDP) and structured data migration processes
Lead cross-workstream alignment to proactively identify, analyze, and remediate data gaps and inconsistencies across systems and processes
Mentor and guide

Skills

Key technologies and capabilities for this role

PLMCMCChemistryManufacturingControlsConfiguration EngineeringDigital Engineering

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 from a specific location?

This information is not specified in the job description.

What are the key responsibilities of the Senior Engineer – Digital CMC PLM role?

The role involves leading collaboration with cross-functional SMEs to define digital product control strategies, overseeing data transfer protocols aligned with CMC standards, and driving configuration and governance of digital PLM systems like QbDVision.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, hires diverse technology professionals for innovative solutions, and emphasizes giving back through philanthropy and volunteerism.

What makes a strong candidate for this Senior Engineer role?

Strong candidates will have hands-on experience in PLM configuration, data migration, quality assurance for manufacturing data, and the ability to collaborate with cross-functional teams in TSMS, QA, and PD while ensuring alignment with global CMC 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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