Test Methods and Systems Engineer

Industry:

Company: Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Test Methods Engineer in IDM Test Methods and Metrology will be responsible for the development, validation, and transfer of the test systems and analytical methods for Lilly’s portfolio of drug delivery devices and primary containers. Work will be conducted and documented in accordance with local and global quality system expectations and regulatory requirements.

Key Objectives/ Deliverables:

• Develop, validate, and transfer analytical methods associated with the current and future portfolio of delivery devices.
• Deploy, qualify, and maintain test systems in support of delivery device and container testing.
• Support the life cycle and ongoing continuous improvement of test systems and analytical methods.
• Develop training material associated with test systems and analytical methods and train personnel in their use.
• Support the periodic review of test systems and analytical methods.
• Participate in investigations associated with products, test systems, and analytical methods.
• Seek compliance and improvements to the Quality and Safety objectives of the organization.

Basic Qualifications:

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

Additional Preferences:

• Experience in a GMP environment
• Experience in drug delivery systems and technologies (e.g., pre-filled and re-usable devices)
• Experience with test system qualification and analytical method development, validation and transfer
• Mechanical aptitude (ideally knowledge of mechanical equipment, controls, and validation for drug delivery devices)
• Knowledge of commercially available precision measuring equipment
• Effective application of statistics and design of experiments
• Awareness of GMP, ISO, and USP requirements relative to drug delivery devices
• Flexibility to work in teams or individually as necessary

Other Information:

This role supports global device design and manufacturing and could require some domestic and international travel.

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Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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