Packaging TSMS Principal Engineer — Greenfield Site Lead

Initial Therapeutics, Inc.; Pleasant Prairie (WI); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

Company bonus

401(k) and benefits

Job summary

Lilly Kenosha County (LKC) packaging leadership role for a greenfield site, guiding the start-up of the packaging program from design input through tech transfer and validation to sustained production. You will ensure state-of-control processes, align with the network, and mentor TSMS colleagues across disciplines.

The position emphasizes regulatory alignment, site consistency, and cross-functional collaboration to deliver packaging excellence and continuous improvement at scale.

Qualifications

• Bachelor's degree or higher in engineering, science, or related field.
• Minimum 5 years of experience in a manufacturing organization.
• Experience supporting cGMP manufacturing operations.
• Strong interpersonal and teamwork skills; autonomous in start-up environments.
• Clear oral and written communication across all levels.

Responsibilities

• Provide technical oversight for packaging materials, equipment, and operations at the LKC site.
• Lead tech transfer, process validation, and PV activities.
• Own the technical agenda for the LKC Packaging TSMS program.
• Provide packaging technical support to operations across materials, equipment, and processes.
• Lead risk assessments and root cause analyses of packaging operations.
• Prepare, review, and provide technical support for change controls, regulatory submissions, deviations, validations.
• Ensure accurate instruction sets and control strategies for manufacturing steps.
• Mentor TSMS engineers and scientists; collaborate with upstream suppliers and global network.
• Support audits, regulatory inspections, and safety initiatives.

Skills

Packaging engineering

cGMP manufacturing

Cross-functional leadership

Oral & written communication

Autonomy in startup environment

Education

Bachelor's or higher in engineering/science

MS in packaging engineering

Tools

SAP

Veeva Vault

Electronic batch records

Microsoft Office

Job description

Lilly Kenosha County (LKC) packaging leadership role for a greenfield site, guiding the start-up of the packaging program from design input through tech transfer and validation to sustained production. You will ensure state-of-control processes, align with the network, and mentor TSMS colleagues across disciplines.

The position emphasizes regulatory alignment, site consistency, and cross-functional collaboration to deliver packaging excellence and continuous improvement at scale.