Sterility Assurance Specialist
4 weeks ago
We are seeking a highly skilled Sterility Assurance Scientist to join our team at Lilly. As a key member of our Parenteral Process Team, you will be responsible for developing and implementing sterility assurance programs, providing technical guidance and expertise in environmental monitoring, contamination control, and aseptic process simulations.
Key Responsibilities
- Develop and implement sterility assurance programs to ensure effective contamination control strategies are established.
- Provide technical support for activities related to sterility assurance programs, including airflow pattern testing, environmental monitoring performance qualifications, and aseptic process simulations.
- Lead or provide technical oversight for the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
- 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.
- 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.
Requirements
- Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
- 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 (Microbiology, TSMS, Sterility Assurance, or related dept).
Preferred Skills
- 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.
About Lilly
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We are a company that unites caring with discovery to make life better for people around the world. We are looking for people who are determined to make life better for people around the world.
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