Engineer – Digital CMC PLM at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Ability to collaborate with cross-functional teams, including Technical Services/Manufacturing Science (TSMS), Quality Assurance (QA), and Process Development (PD)
Knowledge of CMC standards and regulatory requirements
Familiarity with digital PLM systems (e.g., QbDVision), including data structures, metadata standards, version control, and workflow configurations
Skills in data analysis to resolve routine data discrepancies
Experience with data validation, verification, migration, and integrity maintenance
Understanding of GxP, Good Documentation Practices (GDP), and structured data management/migration processes
Capability to participate in system build activities, controlled document updates, and integration with platforms like LIMS, MES, ERP
Ability to contribute to cross-team alignment, identify data gaps, and implement corrective actions under supervision
Capacity to support knowledge transfer and mentoring for junior engineers or team members
Involvement in process optimization, system enhancements, and continuous improvement initiatives

Responsibilities

Collaborate with cross-functional teams to support implementation of digital product control strategies in the PLM system
Assist in the design and execution of data transfer protocols, ensuring adherence to CMC standards and regulatory requirements under the guidance of senior engineers
Support configuration, maintenance, and governance of digital CMC & PLM systems (e.g., QbDVision)
Analyze and resolve routine data discrepancies during production data transfers, escalating complex issues to senior team members
Execute data validation and verification tasks to maintain data integrity and traceability throughout the product lifecycle
Participate in system build activities such as data migration, controlled document updates, and integration support with other manufacturing digital platforms (LIMS, MES, ERP)
Ensure compliance with GxP, Good Documentation Practices (GDP), and structured data management/migration processes
Contribute to cross-team alignment to identify data gaps and implement corrective actions under supervision
Support knowledge transfer and mentoring initiatives for junior engineers or team members
Assist in process optimization, system enhancements, and continuous improvement initiatives to improve PLM

Skills

Key technologies and capabilities for this role

PLMCMCChemistryManufacturingControlsConfiguration EngineeringDigital Engineering

Questions & Answers

Common questions about this position

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

The role involves collaborating with cross-functional teams like TSMS, QA, and PD to implement digital product control strategies in the PLM system, assisting in data transfer protocols adhering to CMC standards, and supporting configuration, maintenance, and governance of digital PLM systems like QbDVision.

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

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the company culture at Eli Lilly emphasize?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, hires diverse technology professionals for innovative solutions, and focuses on creating medicines through advanced tech like data-driven drug discovery.

What makes a strong candidate for this Engineer – Digital CMC PLM role?

A strong candidate has hands-on experience in configuration, data migration, and quality assurance of manufacturing data in digital PLM platforms, with the ability to collaborate cross-functionally and work under senior engineer guidance on CMC standards and regulatory requirements.

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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