Operations Associate - IDM
Listed on 2026-07-27
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Engineering
Regulatory Compliance Specialist, Quality Engineering
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 Operations Associate - IDM (Indianapolis Device Manufacturing) is responsible for working with the Contract Manufacturer(s) (CM) to support supply, quality, and continuous process improvement of Lilly delivery devices, sub-assemblies, and components that are supplied to Lilly packaging and manufacturing sites.
Responsibilities:- Facilitate the Joint Process Team between Lilly and the Contract Manufacturer (CM)
- Compile and communicate monthly JPT metrics
- Foster and support strong Safety and Quality Cultures at the CMs
- Provide day to day oversight of activities and resolve issues occurring between the CMs and Lilly sites
- Lead the resolution of manufacturing related issues, including quality deviations/non-conformances, evaluation of manufacturing data and supply chain daily/weekly issues
- Train to perform activities such as Lead investigator and Change Owner in Lilly's Quality Management System
- Provide operations project management input and oversight for capital projects at CMs
- Work cross functionally with engineering, product stewards and others in the development/leading of process/product improvements. This may include project planning activities, development of protocols, coordination of internal and external lab-based testing, documentation of the data and completion of technical reports
- Track completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews
- Develop collaborative, effective, and productive working relationships with colleagues at CM sites
- Lead multi-functional/cross-site/cross-company project teams as needed
- Escalate critical issues to leadership, as appropriate
- Provide backup, as appropriate, for the Manager – CMO Operations
- Bachelor’s Degree required in a STEM / technical field
- 2 or more years manufacturing experience preferred
- Demonstrated high degree of ownership / accountability
- Strong communication (written and oral) skills, teamwork, and influence
- Technical writing skills
- Ability to organize and prioritize multiple tasks
- Agility to respond to changing priorities
- Previous Leadership/supervisory experience
- Career interest in operations or functional leadership
- Previous engineering or project management experience in medical devices
- Travel required for visits to the CM (15 - 50%).
Qualified applicants must be authorized to work in the United States on a full time basis. Lilly will not provide support for or sponsor the following work authorization or visas for this role: F1, OPT, F1 STEM OPT, J1, H1B, TN, O1, E3, H1B1, or L1.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include:
Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).…
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