Eli Lilly and Company · 6 hours ago
Scientist - TS/MS - Sterility Assurance Technology
Indianapolis, IN
Full-time
Onsite
Mid Level
$66K/yr - $172K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Scientist in Sterility Assurance Technology will provide support for manufacturing facilities, focusing on sterility assurance initiatives and technical leadership in sterility assurance strategies.
BiotechnologyHealth CareMedicalPharmaceutical
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 Flow level
Provide technical guidance 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 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 including risk assessments, justification documents, protocols, and summary reports
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
Provide content and/or data integrity reviews for regulatory submissions
Lead training courses related to sterility assurance programs
Qualification
Required
Bachelor's degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience
Preferred
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing experience
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Experience with data trending and analysis
Analysis and problem solving skills
Quality orientation
Ability to effectively influence
Benefits
Company bonus (depending, in part, on company and individual performance)
401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
Founded in 1876
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
The Motley Fool
2026-01-19
Pharmaceutical Technology
2026-01-19
2026-01-18
Company data provided by crunchbase