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

(Not explicitly listed in the provided job description)

Responsibilities

Collaborate with cross-functional teams, including Technical Services/Manufacturing Science (TSMS), Quality Assurance (QA), and Process Development (PD), 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 PLM systems (e.g., QbDVision), including management of data structures, metadata standards, version control and workflow configurations
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 efficiency and data governance
Accurately execute data migration

Skills

Key technologies and capabilities for this role

PLMCMCConfiguration EngineeringManufacturing SystemsDigital 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 Digital CMC PLM Engineer?

The role involves hands-on configuration, data migration, and quality assurance of manufacturing data within the digital PLM platform, supporting deployments and continuous improvement while collaborating with cross-functional teams.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, putting people first, hiring diverse technology professionals, and focusing on innovative solutions to advance medicine creation.

What skills or experience make a strong candidate for this role?

Strong candidates should have experience with digital PLM systems like QbDVision, ability to collaborate with cross-functional teams in TSMS, QA, and PD, and skills in data transfer protocols adhering to 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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