Lilly Scientist-TS/MS Sterility Assurance 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.
Quick Benefits Overview:
Medical, Dental, Vision, Prescription benefits are effective on your first day of employment
Paid vacation- starting annually at 120 hours (prorated based on start date)
Eligible for annual bonuses
The Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group are positions that provide support for control of the sites manufacturing facilities. Are you looking to make an impact on a deep technical level to the way we manufacture medicine safely and efficiently? Our group develops and implements sterility assurance related initiatives and provides technical leadership to the site!
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 line level.
Provide technical mentorship to the Flow and Process Teams for sterility assurance programs.
Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
Lead or provide technical support for root cause investigations.
Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the possibility for introduction of microbial, endotoxin and particulate contamination.
Complete and assist in the development of process and facility monitoring strategies that focus on areas of the highest microbial risk.
Lead site aseptic self-inspection program including communication of observations and recommendations for improvements to manufacturing and support personnel.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for improvements.
Build, implement, review and/or approve technical documents and change controls related to sterility assurance programs including risk assessments, justification documents, aseptic process simulation protocols, and summary reports.
Engage in or provide guidance during regulatory audits. Provide content and/or data integrity reviews for regulatory submissions.
Bachelor's Degree in STEM field (microbiology or biology preferred)
3 years of experience in a regulated environment (aseptic processing and/or sterility assurance experience preferred)
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing or product protection control strategy experience
Experience with data trending and analysis
8 hour days – Monday through Friday
Overtime may be required
Work in a multifaceted and fast-paced environment
5 – 10% Travel Required
Applicant 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 position
On call rotation (by phone) may be required
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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).