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.
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:
Provide leadership for FUME, Environmental Monitoring (EM) to support aseptic control of manufacturing facilities. Develop and implement FUME, EM and other sterility assurance initiatives to support quality in manufacturing.
- Ensure FUME and EM Programs meet or exceed agency guidelines.
- Provide technical guidance to Operations and other support areas regarding FUME, EM and sterility assurance matters.
- Provide review and approval of FUME and EM Evaluation reports and Data Review to support batch release.
- Provide technical support for FUME and EM initiatives involving viable, nonviable, personnel monitoring. Manage procedural revisions, if needed.
- Proactively drive FUME and EM projects that support operations, sterility assurance initiatives, and regulatory commitments.
- Participate in the continuous improvement of quality performance.
- Perform root cause investigation of EM and/or FUME non-conformances.
- 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 Microbiology or related science.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- Experience in Environmental Monitoring and/or Utilities Monitoring.
- Experience with data trending and analysis.
- CAPA Lead Investigator - Root Cause Analysis certification.
- Change Control Subject Matter Expert.
- Experience with MODA/Darwin
- Bachelors of Science in Microbiology or related science
- Must complete ITP for EM/FUME Microbiologist.
- Known allergens in area.
- Work in a dynamic and fast paced 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.? We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!