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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$17.30 - $39.06

Organization Overview:

Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.

Position Brand Description:

The Lead Technician-QC-IDM is primarily responsible for providing technical support and expertise for work processes and activities associated with laboratory equipment and batch release qualification. Equipment process/activities include the development and delivery of equipment, equipment associated OJT courses, and the laboratory equipment maintenance program. Batch release process/activities include supporting lab investigations, reviewing deviations, and the development review, and instruction of procedures and training.

Key Objectives/Deliverables:

Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly’s and the industry’s application.Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory.Provide Quality Control support for the IDM QC laboratory.Author, maintain, and instruct on OJT courses for testing inspection and laboratory operations.Perform and oversee QC laboratory equipment setup, operation, and maintenance.Build and maintain working relationships with DDR&D, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product.Participate in new product design and pre-launch preparation projects to support laboratory equipment validation and device testing.Participate in departmental process improvement activities.Maintain IDM QC laboratory testing schedule.Maintain IDM QC laboratory inventory management.Support and perform laboratory device testing for commercial and development product.Provide strategic and tactical support to drive technical training within laboratory operations.Participate in regulatory agency and internal inspections.Ensure that all test equipment is properly validated and maintained for its intended use.Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of an Analytical Investigation (AI) as appropriate.Support Change Management through roles of originator and/or executor of tasks and implementation steps.Review and approve OJT courses associated with laboratory operations and batch release qualification and associated workshops.

Minimum Requirements:

Minimum of 5 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL).Experience developing training materials.Strong problem solving and analytical thinking skills.Experience with Parenteral products, dry products, or devices.Experience with QualityDocs and Trackwise.Strong verbal and written communication skills in English.Self-management/motivated.Demonstrated computer literacy in Outlook, Windows, and Microsoft applications.Excellent teamwork and ability to multi-task.Strong curiosity skills with the ability to question/identify issues and work to resolution.Strong critical thinking/problem solving skills with an ability to apply rationale.

Additional Preferences:

Three year experience in Quality or TS/MS support.Attention to detail.Experience with Microsoft Office Suite and LillyNet Collaboration Sites.Above average computer literacy and computer skills-specific training related to software used will be provided.Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems.Ability to mentor/train others-share learning.Prior experience with GMARs and maintenance of equipment or instruments.

Education Requirements: High School diploma or GED required, with some post-secondary education or associated degree preferred.

Other Information:

The position is day shift. Occasional after-hours and year-end holiday coverage may be required.

10% limited travel may be required for OUS and domestic travel.

The job responsibilities of this position support the technical ladder process.

This position is located at LTC-North in IDM

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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