Test Methods and Systems Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

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* Basic Qualifications:

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* + 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:*
* + Bachelor of Science degree in engineering or STEM related science field preferred.

+ Minimum 4 years of manufacturing or engineering experience preferred.

+ Experience in a GMP environment

+ Experience in drug delivery systems and technologies (e.g., pre-filled and re-usable devices)

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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 10-20% domestic and international travel.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

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Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network…