Sterility Assurance Scientist , Technical Services / Manufacturing Sciences

Sterility Assurance Scientist

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 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.

Position Overview

The Sterility Assurance Scientist helps ensure our manufacturing processes meet the highest standards of cleanliness and contamination control. This role supports and improves site programs related to sterility assurance and provides technical guidance in areas such as:

• Environmental monitoring
• Contamination control
• Aseptic (sterile) processing techniques
• Cleanroom gowning practices
• Cleaning and sanitization (including disinfectant effectiveness)

At the Principal level, this role also leads technical strategy, provides guidance to the Parenteral Process Team, mentors team members, and supports broader company initiatives related to sterility assurance.

Key Responsibilities

• Provide technical support and guidance for sterility assurance programs on the manufacturing floor
• Support or lead activities such as:
• Airflow testing
• Environmental monitoring (EM)
• Aseptic process simulations (APS)
• Cleaning, sanitization, and disinfection
• Cleanroom gowning and aseptic practices
• Help develop and improve contamination control strategies and facility monitoring programs
• Analyze data to identify trends, issues, and improvement opportunities
• Support or lead investigations into contamination or sterility-related issues
• Participate in internal and external audits
• Write, review, and approve technical documents and change controls
• Work cross-functionally to meet quality and business objectives

Senior-level Additional Responsibilities:

• Lead development of contamination control strategies and cleaning/sanitization programs
• Support gowning and aseptic technique programs

Principal-level Additional Responsibilities:

• Provide technical leadership for Environmental Monitoring (EM) and/or Aseptic Process Simulation (APS) programs
• Review data, write reports, and ensure compliance with quality standards
• Mentor team members and contribute to site-wide and external sterility initiatives
• Apply risk management to evaluate contamination risks (microbial, endotoxin, particulate)

Basic Qualifications

• Bachelor's degree in microbiology, Biology, Biochemistry, Engineering, or a related field
• 2+ years of experience in cGMP manufacturing (e.g., quality, validation, operations, or technical services) preferred
• Understanding of sterile manufacturing and contamination control principles
• Experience in pharmaceutical manufacturing preferred
• 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 Skills

• Able to work in cleanroom environments and wear required PPE
• Strong teamwork and communication skills
• Good organization and time management
• Experience analyzing and trending data

Additional Information

• May need to support off-shift issues occasionally
• Primary location: Kenosha County, WI
• Up to 10% travel

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.