Lead Scientist, Device Assembly & Process Validation

Eli Lilly and Company; Pleasant Prairie (WI); On-site; USD 68,000 - 174,000; Full time

Job summary

Lilly seeks a seasoned Device Assembly TSMS Principal Scientist to lead the foundational device assembly program at the Kenosha County site. You will drive the technical agenda from equipment design input through tech transfer, validation, and sustaining commercial support.

The role requires 5+ years in pharma or medical device manufacturing, strong leadership, and the ability to collaborate across cross-functional teams while maintaining regulatory alignment.

Qualifications

• BS or MS in engineering or related scientific discipline.
• Minimum of 5 years directly supporting pharmaceutical or medical device manufacturing.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills, with the ability to operate with a high degree of autonomy in a start-up environment.
• Oral and written communication skills that demonstrate an ability to effectively communicate with all levels of the organization.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Develop and implement the technical agenda for device assembly at the greenfield LKC site, including tech transfer and PV readiness.
• Provide technical support for start-up activities (tech transfer, equipment/process qualification, process validation).
• Lead non-routine investigations related to device assembly (deviations, complaints).
• Prepare, review, and support for technical documents (change controls, regulatory submissions, validation plans/reports).
• Ensure device assembly processes and control strategy are accurately described in instruction sets.
• Own the technical agenda for assigned device assembly products, platforms, or validation processes.
• Lead risk management activities for device assembly products and processes.
• Develop, monitor, and react to real-time metrics for process variability and capability.

Skills

Strong interpersonal

Teamwork

Self-management

Organizational skills

Oral and written communication

Education

BS or MS in engineering or related scientific discipline

Job description

Lilly seeks a seasoned Device Assembly TSMS Principal Scientist to lead the foundational device assembly program at the Kenosha County site. You will drive the technical agenda from equipment design input through tech transfer, validation, and sustaining commercial support.

The role requires 5+ years in pharma or medical device manufacturing, strong leadership, and the ability to collaborate across cross-functional teams while maintaining regulatory alignment.