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Analytical Instrument Qualification Scientist

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 24, 2024

Job Details

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.

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.  

 

Responsibilities: 

The Global Analytical Instrument Qualification (GAIQ) team provides technical support for the qualification of analytical instrumentation in the M&Q QC Labs. This includes selection of instruments, qualification, validation, and defining best practices during the instrument lifecycle. The responsibilities of the Analytical Instrument Qualification Scientist include: 

 

  • Define standardized global process to qualify and validate analytical instruments, ensuring compliance with applicable compendia and analytical method requirements, data integrity and computer system validation expectations.  

  • Ensure analytical instrument qualification is compliant with Quality Lilly Standards, compendia and other relevant regulations, e.g., CFR 21 part 11 and GAMP. 

  • Create or review standard operating procedures and training materials for the analytical instrument qualification and validation process. 

  • Create and maintain document templates for instrument qualification in Kneat. 

  • Owning change controls for qualified instruments, including requirements changes and system upgrades. 

  • Participation in the cross functional team consisting of GAIQ, IT, Engineering Automation and Data Management to ensure connectivity of analytical instrumentation to electronic documentation systems.  

  • Acting as liaison with analytical instrument vendors, executing manufacturer evaluations, communicating issues or feature requests.  

  • Evaluating analytical instrument capability. Understanding and interpreting direction of technology and the impact on laboratory business processes, quality systems and the QC organization. 

  • Providing leadership and technical guidance for the M&Q QC labs through the instrument lifecycle from instrument acquisition to retirement. 

  • Creating or performing technical review of analytical instrument qualification documents. 

  • Creating or performing technical review of computer system validation documents for software or firmware linked with analytical instruments.  

  • Providing support and involving the necessary SMEs on issues impacting multiple sites. 

  • Supporting site audits and inspections related to the GAIQ process. 

  • Execute audit trail review assessments.  

  • Provide oversite to instrument qualification execution in GQL.  

 

 

Basic Qualifications 

  • Bachelor’s Degree or equivalent experience in Chemistry, Biology, Engineering, Pharmacy, Computer Science or a closely related field 

  • Minimum 3-5 years of experience working with instrument qualification and validation in a GMP environment.  

 

Additional Preferences 

The ideal candidate will have a strong scientific background; tenacity; organizational skills; demonstrated strong decision making; learning flexibility/agility; effective communication/presentation skills; possess a clear understanding of quality activities; experience in defining and improving business processes; motivation to deliver. In addition to these qualities, there's also a strong preference for the following: 

  • Extensive knowledge of different analytical technologies, laboratory documentation, control processes and data integrity principles. 

  • Clear understanding of quality laboratory issues and activities. 

  • Ability to troubleshoot issues related with analytical instruments. 

  • Experience in defining and improving business processes. 

  • Knowledge of cGMP and quality systems, including data integrity 

  • Ability to work independently and in a team setting. 

  • Experience using Kneat, Trackwise and GMARS 

  • Experience in computer system validation (CSV)

 

Additional Information 

Individual must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements. Travel (domestic and/or international) may be required. Individual may also be asked to physically relocate to a manufacturing site to aid in deployment and/or support site business processes. Flex hours are possible to help support work/life balance. 

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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