Test Methods and Systems Engineer

Eli Lilly - Indianapolis, IN

Full-time

Indianapolis, IN

Chemical Manufacturing

About the position

The Test Methods Engineer at Eli Lilly will focus on the development, validation, and transfer of test systems and analytical methods for drug delivery devices and primary containers. This role is crucial in ensuring compliance with quality systems and regulatory requirements while supporting continuous improvement initiatives.

Responsibilities

• Develop, validate, and transfer analytical methods for drug delivery devices.
• Deploy, qualify, and maintain test systems for delivery device and container testing.
• Support the life cycle and continuous improvement of test systems and analytical methods.
• Create training materials and train personnel on test systems and analytical methods.
• Conduct periodic reviews of test systems and analytical methods.
• Participate in investigations related to products, test systems, and analytical methods.
• Ensure compliance with Quality and Safety objectives.

Requirements

• Bachelor of Science degree in engineering or related science field preferred.
• Minimum 4 years of manufacturing or engineering experience preferred.
• Ability to work across functional and geographic boundaries.
• Strong problem-solving skills in mechanical, electrical, software, and system domains.
• Excellent written and oral communication skills, including technical writing.

Nice-to-haves

• Experience in a GMP environment.
• Experience in drug delivery systems and technologies.
• Experience with test system qualification and analytical method development.
• Mechanical aptitude with knowledge of mechanical equipment and controls.
• Knowledge of precision measuring equipment.
• Effective application of statistics and design of experiments.
• Awareness of GMP, ISO, and USP requirements.

Benefits

• Equal opportunity employer with support for individuals with disabilities.
• Employee resource groups for diverse communities.