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.

Overview:

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 35,000 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.

Responsibilities:

The primary responsibilities of the Quality Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of

Indianapolis Device & Assembly Packaging (IDAP) site. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

Promote safety awarenessRemain current with individual training planObserve, promote, and follow requirements related to safety, quality, security, customer service, and GMPsProvide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint managementProvide quality oversight and provide quality support for bringing new products into IDAPProvide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Technicians floor decisionsRaise notification to management for departures of critical nature and assure issues are addressedAssess gaps between local and corporate standards and facilitate remediation efforts actively working with support areasEnsure area is always audit readySupport project timelines assuring compliance with Quality expectationsProactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team membersPossess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.Actively assist in continuous improvements and efficiency projectsProvide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processesActively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participationProvide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automation

Basic Qualifications:

Bachelor's Degree in STEM

Additional Skills/Preferences:

3 or more years' experience in a GMP environment preferredPrevious experience in Quality Assurance or Engineering preferredKnowledge of cGMPs, Production Processes, Quality Systems, and FDA regulationsExperience supporting computer systems (e.g. CSV, CSQ, IDS experience)Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality DocsExperience in conducting root cause investigations, and execution of change management, equipment qualification, and process validationAbility to communicate effectively with customers to carry out requirementsAbility to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solveAbility to influence team interactions and lead initiativesDemonstrated strong oral and written communication and interpersonal skillsDemonstrated decision making and problem-solving skillsDemonstrated knowledge and understanding of manufacturing process and Quality SystemsDemonstrated attention to detailDemonstrated ability to coordinate and prioritize multiple tasks.

Additional Information:

Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needsOvertime and weekend work may be required.Individual must be available via cell phone (on-call)Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.Some travel may be required

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

$63,000 - $140,800

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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