Senior/Principal Process Engineer at Eli Lilly and Company

Lebanon, 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, Biotechnology, HealthcareIndustries

Requirements

Bachelor's Degree in Chemical, Biochemical, Pharmaceutical, Biomedical, or Mechanical Engineering
3+ years of relevant experience in manufacturing operations (prefer chemical, pharmaceutical)

Responsibilities

Provide Process Engineering support to the Global Facility Delivery team with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness)
Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, Performance Qualification requirements/protocol development, etc.)
Own the Performance Qualification execution for area of responsibility
Develop and implement unit operation and equipment control strategy to sustain and optimize API processes
Support initial Operations Training requirements as the Equipment and Area SME
Lead/support the tech transfer of new processes into the facility
Provide process engineering support in batch API supply or continuous platforms through application of chemical engineering fundamentals
Monitor, assess and document equipment performance to maintain ongoing qualification
Develop and maintain the basis of safety for process equipment
Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control
Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team
Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms
Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions

Skills

Process Engineering

GMP Manufacturing

Facility Start-up

Operational Readiness

Performance Qualification

SOP Development

C&Q

Process Safety Assessments

Automation Optimization

User Requirements

Design Reviews

ATMP

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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