Lead Device Assembly Scientist – Greenfield Site

BioSpace; Pleasant Prairie (WI); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

Company bonus

401(k)

Health, dental, vision benefits

Vacation benefits

Flexible spending accounts

Job summary

Lilly seeks a Device Assembly TSMS Principal Scientist to build the technical foundation for start-up and manufacturing at the Kenosha County site in Wisconsin. You will shape the process control strategy, support tech transfer, and drive validation readiness for commercial production.

As the site expert on regulatory and internal requirements for device assembly, you will lead cross-functional teams, ensure quality and safety, and align with the global network.

Qualifications

• BS or MS in engineering.
• Minimum of 5 years directly supporting pharmaceutical or medical device manufacturing.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills, with autonomy in a start-up environment.
• Oral and written communication skills that communicate clearly 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 LKC greenfield site.
• Lead tech transfer, equipment qualification, and process validation in readiness for PV ramp.
• Ensure regulatory and internal requirements for device assembly are met across the product lifecycle.
• Provide technical support for deviations, investigations, and change controls.
• Collaborate with upstream suppliers, equipment vendors, and global teams to drive consistency.

Skills

Engineering degree

5+ years experience

Startup environment

Autonomous work

Education

BS/MS in engineering

Tools

Tech transfer

Equipment qualification

Process validation

cGMP compliance

Job description

Lilly seeks a Device Assembly TSMS Principal Scientist to build the technical foundation for start-up and manufacturing at the Kenosha County site in Wisconsin. You will shape the process control strategy, support tech transfer, and drive validation readiness for commercial production.

As the site expert on regulatory and internal requirements for device assembly, you will lead cross-functional teams, ensure quality and safety, and align with the global network.