Eli Lilly and Company · 7 hours ago
TSMS Sterility Assurance Scientist
Pleasant Prairie, WI
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The Sterility Assurance Scientist role involves developing and implementing sterility assurance programs, providing technical guidance in contamination control and aseptic techniques, and leading efforts related to environmental monitoring and cleaning strategies.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level
Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to: Airflow Pattern Testing, Environmental Monitoring Performance Qualifications, Aseptic Process Simulations, Cleaning, Sanitization, and Disinfection, Gowning within GMP Classified Areas, Aseptic Processing Techniques, Contamination Control
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established
Lead/assist with support and/or provide technical expertise for developing the site’s contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies
Lead/assist with support and/or provide technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program
Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification
Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program: (EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution. (EM) Evaluating EM data and authoring EM Trend Reports. (EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures. (APS) Authoring APS protocols and overseeing the execution. (APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports. (APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements
Lead or provide technical support for root cause investigations associated with sterility assurance programs
Participate and/or provide technical sterility assurance support during internal and external audits
Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs
Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives
Qualification
Required
Bachelor's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferred
Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing
2+ years in pharmaceutical manufacturing preferred (Microbiology, TSMS, Sterility Assurance, or related dept)
Possess strong interpersonal skills to work cross-functionally within a team
Possess strong self-management and organizational skills
Possess strong oral and written communication skills for communicating to colleagues, management, and other departments
Experience with data analysis and trending
Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities
Benefits
Company bonus
Company-sponsored 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.
10001+ employees
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
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2026-01-25
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