Sterility Assurance Scientist , Technical Services / Manufacturing Sciences

Lilly • Pleasant Prairie, WI

1d • $66,000 - $171,600 • Onsite

About The Position

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.

Requirements

• 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 and 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

Nice To Haves

• 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

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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior