Sterility Assurance Scientist , Technical Services / Manufacturing Sciences
Eli Lilly and Company
5 days ago
On-site
Pleasant Prairie, WI
Operations
Position Overview
The Sterility Assurance Scientist helps ensure manufacturing processes meet standards for cleanliness and contamination control. Supports and improves site sterility assurance programs and provides technical guidance in:
- Environmental monitoring
- Contamination control
- Aseptic (sterile) processing techniques
- Cleanroom gowning practices
- Cleaning and sanitization (including disinfectant effectiveness)
At the Principal level, 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: 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 EM and/or 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 related field
- 2+ years cGMP manufacturing experience preferred
- Understanding of sterile manufacturing and contamination control principles
- Pharmaceutical manufacturing experience preferred
- Authorized to work in the U.S. full-time; Lilly will not sponsor visas
Preferred Skills
- Able to work in cleanrooms 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
The Sterility Assurance Scientist helps ensure manufacturing processes meet standards for cleanliness and contamination control. Supports and improves site sterility assurance programs and provides technical guidance in:
- Environmental monitoring
- Contamination control
- Aseptic (sterile) processing techniques
- Cleanroom gowning practices
- Cleaning and sanitization (including disinfectant effectiveness)
At the Principal level, 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: 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 EM and/or 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 related field
- 2+ years cGMP manufacturing experience preferred
- Understanding of sterile manufacturing and contamination control principles
- Pharmaceutical manufacturing experience preferred
- Authorized to work in the U.S. full-time; Lilly will not sponsor visas
Preferred Skills
- Able to work in cleanrooms 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