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. **Organization Overview:** At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description: To provide equipment lifecycle management support to the Parenteral QCL. Main support functions include specifying and purchasing equipment; authoring Equipment Qualification (EQ) and Computer System Validation (CSV) packages, managing the EQ and CSV processes, and providing daily operational support of laboratory by ensuring the equipment and associated computer systems are maintained in a qualified state of compliance. The position requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical laboratory equipment and computer systems, knowledge of lab methods to understand intended use of equipment and their failure modes effects. High-quality skills to include: equipment troubleshooting, ability to prioritize, written and oral communication, decision making, interpersonal/people, computer applications, problem solving. **Responsibilities:** + Responsible for design and execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity. + Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices, and local procedures in the development of qualification / validation protocols and equipment lifecycle management. + Interact effectively with customers, support groups, and development. + Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met. + Influence improvements and streamline quality systems relating to equipment. + Serve as equipment expert and technical resource in the review of technical documents. + Act as subject matter expert and originator of change controls. + Originate and investigate TrackWise CAPA records. + Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment. + Ability to multitask, prioritize, and coordinate work to meet customers’ needs. + Demonstrate problem solving and investigative skills. + Ability to make decisions based on knowledge, experience, best practices, and requirements. + Ability to work independently and accurately with minimal supervision. **Basic Qualifications:** + Bachelor’s degree in scientific field related to the lab (Chemistry / Biology / Microbiology / Engineering / IT) with at least 2 years laboratory experience in QC or development lab with emphasis on laboratory equipment. + Would consider candidates with Associate's degree with 3-5 years of laboratory experience with emphasis on laboratory equipment. **Additional Preferences:** + Ability to interpret & apply regulations such as 21CFR Part 11, 210/211, 820. + Familiarity or proficiency with GAMP or other industry methodologies. + Ability to define validation approach for various equipment. + Familiarity or proficiency with computer systems including Microsoft Office products, laboratory computer systems (e.g., Empower, WinKQCL, SoftMax Pro, etc.), CMMS (e.g., GMARS), SmartLab (or other ELN), Darwin (LIMS), MODA, TrackWise, and Quality Docs (EDMS). + Computer system validation experience including computer system networking, system architecture and data lifecycle management, basic scripting. + Ability to work in a lab environment including wearing appropriate PPE and other safety required equipment and considerations. + Ability to work independently and accurately with minimal supervision. + Ability to make decisions based on knowledge, experience, best practices and requirements. + Ability to multitask, prioritize and coordinate work to meet customer's needs. + Demonstrated strong math and documentation skills. + Demonstrated strong technical oral and written communication skills. + Demonstrated problem solving and investigative skills. **Additional Information:** + Ability to work 8 hour days – Monday through Friday. + Ability to cover weekends, holidays, and company shutdowns as needed. + Ability to work additional hours to meet manufacturing or laboratory demands as required. + Ability to carry cell phone off shift and respond to operational issues as required. + Minimal travel required. + Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position. 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 - $162,800 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. \#WeAreLilly