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Lilly Principal Scientist Environmental Monitoring in Indianapolis, Indiana

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.

Organization Overview:

Provide technical leadership for Environmental Monitoring (EM) and FUME to support aseptic control of manufacturing facilities. Develop and implement EM, FUME and other sterility assurance initiatives to support quality in manufacturing.

Responsibilities:

  • Ensure EM Programs and FUME meet or exceed agency guidelines.

  • Provide technical mentorship to Operations and other support areas regarding EM, FUME and sterility assurance matters.

  • Provide review and approval of EM and FUME Evaluation reports and Data Review to support batch release.

  • Provide technical support for initiatives involving viable, nonviable, personnel monitoring. Lead procedural revisions, if needed.

  • Proactively drive projects that support operations, sterility assurance initiatives, and regulatory commitments.

  • Perform root cause investigation of EM and/or FUME non-conformances.

Basic Requirements:

  • Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service.

  • Strong technical writing skills and proficiency in technical review of documents.

  • Bachelor degree (4 yr) in STEM (Microbiology preferred) or related science.

  • 4 years of related experience

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Skills/Preferences:

  • Experience in Environmental Monitoring and/or Utilities Monitoring.

  • Experience in sterility assurance in cGMP environment

  • Experience with data trending and analysis.

  • CAPA Lead Investigator - Root Cause Analysis certification.

  • Change Control Subject Matter Expert.

  • Experience with MODA/Darwin

Additional Information:

  • EM/FUME sterility assurance microbiologist.

  • Known allergens in area.

  • Work in a multifaceted and fast paced cGMP environment.

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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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