IDM TS/MS Product Steward (R2-R3)

Eli Lilly and Company • Us, IN

1d • Onsite

About The Position

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. Eli Lilly and Company seeks an IDM TS/MS Product Steward (R2-R3) to develop potential product and process improvements. Responsible for design control, validation and verification activities, and manufacturing control strategy. Develop specifications, protocols, sampling plans, engineering studies, and technical reports. Provide support to product lifecycle management and monitoring processes. Organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings and lead on multi-functional project teams. Lead root cause investigation team to develop and implement corrective and preventative actions. Participate in and support CMO Joint Process Teams to meet manufacturing objectives. Participate in Design and Manufacturability reviews. #LI-DNI Position requires a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field and 3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment. Experience must include a minimum of: 3 years of experience working with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices; 3 years of experience driving continuous improvement of test systems and validation processes; 3 years of experience leading analytical evaluations of events and deviations associated with products, test systems, and analytical methods; 3 years of experience working with device platforms, including design, materials of constructions, manufacturing process, and quality systems; 3 years of experience working with Primary Loop, Operational Excellence, and Root Cause Analysis; and 3 years of experience working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820,ISO 13485, and ISO11608. Up to 10% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-103503 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285. 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 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). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $101,254.00 per year 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. #WeAreLilly

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field
• 3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment.
• 3 years of experience working with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices
• 3 years of experience driving continuous improvement of test systems and validation processes
• 3 years of experience leading analytical evaluations of events and deviations associated with products, test systems, and analytical methods
• 3 years of experience working with device platforms, including design, materials of constructions, manufacturing process, and quality systems
• 3 years of experience working with Primary Loop, Operational Excellence, and Root Cause Analysis
• 3 years of experience working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820,ISO 13485, and ISO11608
• Up to 10% domestic and international travel required.

Responsibilities

• Develop potential product and process improvements.
• Responsible for design control, validation and verification activities, and manufacturing control strategy.
• Develop specifications, protocols, sampling plans, engineering studies, and technical reports.
• Provide support to product lifecycle management and monitoring processes.
• Organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings and lead on multi-functional project teams.
• Lead root cause investigation team to develop and implement corrective and preventative actions.
• Participate in and support CMO Joint Process Teams to meet manufacturing objectives.
• Participate in Design and Manufacturability reviews.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees