Scientist - TS/MS Sterility Assurance Technology

1 month ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.

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:

The Scientist position in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group provides support for control of the site's manufacturing facilities. The group develops and implements sterility assurance related initiatives and provides technical leadership with regard to sterility assurance strategies.

Responsibilities:

Ensure site's Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management and other sterility assurance programs are followed at the manufacturing floor level.Provide technical guidance to the Process Team for sterility assurance programs.Create and review periodic review of environmental monitoring data.Lead or provide technical support for root cause investigations for sterility assurance programs.Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.Lead site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.Create, execute, review and / or approve technical documents related to sterility assurance programs.Create, execute and / or review change controls related to sterility assurance programs.Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.Participate in continuous improvement projects to improve quality performance at the site.Participate or provide guidance for sterility assurance programs during regulatory audits.Basic Qualifications: Bachelors Degree in Microbiology, Biology or related STEM field.Additional Skills/Preferences:Experience with data trending and analysisAnalysis and problem-solving skillsQuality orientationAbility to effectively influenceResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Understanding of GMPs and applicable internal standardsCommunication (oral and written) skills; technical writing skillsTeamwork / interpersonal skillsAdditional Information: 8 hour days – Monday through FridayOvertime may be requiredWork in a dynamic and fast-paced environment5 – 10% Travel RequiredApplicant will work in various areas within the Parenteral Site. Some allergens are present.Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this positionOn call rotation (by phone) will be required 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 ( ) 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

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