Contract Manufacturing Lead Process Engineer – Indy Device Manufacturing at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical Devices, ManufacturingIndustries

Requirements

Minimum 3 years engineering experience in automated assembly equipment
Root Cause Analysis, Investigation and Problem Solving skills
Strong communication, teamwork, and networking skills
Training, coaching and mentoring experience
Proven ability to organize and prioritize multiple tasks
Strong attention to detail
BS in an Engineering or Engineering related field
Ability to travel 25% on average with peak over 50% for a few months at a time

Responsibilities

Obtain technical expertise of equipment and processes in area of responsibility, including clear understanding of equipment flow chart/process flow document, and critical process parameters for the process
Develop and provide training, technical oversight and mentorship to CMO process engineers
Provide program management support for CMO process engineers across multiple sites to evaluate reliability improvement projects, replicate across similar lines in the platform network and the shutdown management of those projects
Work with external companies and project teams to develop product and process improvements
Evaluate scope and business cases for proposed capital improvement projects
Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process
Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda
Support/lead the resolution of escalated manufacturing related issues, including deviations, investigations and evaluation of manufacturing data and supply chain coordination issues
Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues
Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews
Develop effective and productive working relationships with colleagues at CM sites
Define and mitigate technical and patient risks, including use of FMEA

Skills

Process Engineering

Critical Process Parameters

Process Flow Documentation

Program Management

Reliability Engineering

Continuous Improvement

Project Management

Training

Mentoring

Contract Manufacturing

OEM Support

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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