Sr. Principal Engineer – TSMS Visual Inspection at Eli Lilly and Company

Pleasant Prairie, Wisconsin, 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

Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems
Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations
Perform root cause analysis and apply scientific principles and understanding related to defect creation, prevention, and detection
Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, validation protocols and summary reports, defect classifications, technical studies, regulatory submissions, etc
Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
Serve as technical interface external to the Kenosha site
Provide audit support, as needed
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Responsibilities

Provide technical guidance for visual inspection operations and projects involving existing and new inspection processes
Teach, mentor, and coach personnel in all aspects relating to visual inspection processes within the Lilly Kenosha County site
Oversee visual inspection operations for commercially manufactured products at the Kenosha site
Manage the training and qualification program associated with visual inspection, classification of defects, and ensuring overall scientific understanding of the program
Participate in troubleshooting and driving continuous improvement as it relates to the visual inspection program
Regularly interact with peers within the parenteral network and in Global TS/MS to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations

Skills

Visual Inspection

Parenteral Manufacturing

Defect Classification

Training

Mentoring

Troubleshooting

Continuous Improvement

Technical Services

Manufacturing Science

Regulatory Guidance

Quality Assurance

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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