TSMS Sterility Assurance Scientist
Eli Lilly and Company
Full-time
On-site
Pleasant Prairie, WI
$66,000 - $171,600 USD yearly
Operations
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Role Summary
TSMS Sterility Assurance Scientist
Responsibilities
- The Sterility Assurance Scientist assists in development and implementation of the site’s sterility assurance programs and provides technical guidance in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. Provides technical leadership for the Parenteral Process Team and mentors the TSMS team, engaging in upstream and external activities related to sterility assurance.
- Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
- Provide technical support for activities related to sterility assurance programs including:
- 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 with developing the site’s contamination control strategy and cleaning/sanitization program and disinfectant efficacy strategies.
- Lead/assist with the facility’s cleanroom gowning and aseptic technique strategy/program.
- Knowledge in pharmaceutical Microbiology, including microbiological media, enumeration techniques, and microorganism isolation/identification.
- Lead/provide technical oversight for the Environmental Monitoring or Aseptic Process Simulation program, including authoring and overseeing PQs, evaluating data, and authoring reports.
- Apply sterility assurance risk management to evaluate manufacturing processes for potential microbial, endotoxin, and particulate contamination.
- Analyze microbial and manufacturing data to identify trends and opportunities for continuous improvements.
- Lead or provide technical support for root cause investigations related to sterility assurance.
- Participate in internal and external audits and create, execute, review, and approve technical documents and change controls related to sterility assurance.
- Collaborate within cross-functional teams to deliver on TS/MS objectives and quality goals.
Qualifications
- Required: Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
- Preferred: 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept).
Skills
- Demonstrated understanding of principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance in cGMP pharmaceutical manufacturing.
- Strong interpersonal, self-management, organizational, and communication skills.
- Experience with data analysis and trending.
- Ability to wear PPE and gown into cleanroom attire as required.
Education
- Bachelor’s Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related field.