Principal Process Engineer at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Demonstrate strong ownership for equipment and packaging areas, being flexible, proactive, and involved
Possess deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines
Serve as a responsible engineer for site process lines, ensuring equipment is maintained in its validated state (AQM)
Approve scopes of qualifications, re-qualification monitoring activities, significant changes, maintenance, and interventions for potential impact on safety or quality
Provide equipment and processing support for production issue resolution and investigation using data analysis and first principles
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals
Support site inspection readiness, execution, and direct interaction with Regulatory Agencies
Develop local processes and procedures using lean tools, first principles, and theoretical knowledge to enhance efficiency
Utilize in-depth understanding of materials, processes, and equipment to improve process robustness, reduce variability, and increase operational uptime
Foster knowledge sharing, education, and collaboration with internal/external partners and cross-functional teams (quality, technical services, operations)
Mentor and coach technical resources on scientific approaches, technology, business behaviors, first principles, change/deviation management, and issue resolution
Create a safe and encouraging environment for idea sharing and contributions

Responsibilities

Provide technical oversight for development and optimization of automated assembly processes
Accountable for technical aspects of quality direct impact systems and critical components in production, testing, packaging, labeling, and storing
Maintain reliable supply of products across the site
Review and/or approve significant changes, maintenance, and interventions for impact on equipment/process safety or quality
Identify and drive improvement opportunities
Support complex site investigations of key safety and production issues, including identification and implementation of CAPA plans
Support site inspection readiness and execution, with direct interaction with Regulatory Agencies
Develop local processes and procedures to enhance efficiency using lean tools
Use first principles and theoretical knowledge to define scientific approaches for technical improvements
Collaboratively integrate disciplines on projects and process performance improvements
Mentor and coach other technical resources

Skills

Key technologies and capabilities for this role

Process EngineeringAutomated AssemblyPackaging LinesEquipment ValidationProcess QualificationChange ControlMaintenance InterventionsUnit Operations

Questions & Answers

Common questions about this position

What is the salary for the Principal Process Engineer position?

This information is not specified in the job description.

Is this Principal Process Engineer role remote or onsite?

This information is not specified in the job description.

What key skills are required for the Principal Process Engineer role?

The role requires deep knowledge of equipment and unit operation design on assembly and packaging lines, expertise in data analysis and first principles applications for problem-solving, proficiency in lean tools for process optimization, and strong understanding of cGMP standards, OSHA regulations, and regulatory compliance.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and values giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for the Principal Process Engineer position?

Strong candidates demonstrate strong ownership by being flexible, proactive, and involved as a technical SME, excel in innovation and problem-solving with reliable solutions and CAPA implementation, ensure regulatory compliance, and drive process optimization using lean tools.

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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