What are the responsibilities and job description for the Senior Sterility Assurance Scientist position at BioSpace?
Job Details
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.
Responsibilities :
The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning / aseptic techniques, and cleaning / sanitization strategies, including disinfectant efficacy.
Key Objectives / Deliverables :
- Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
- Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to; 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 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.
- Work within cross-functional teams to implement TS / MS objective and deliver on business and quality objectives.
Basic Qualifications :
Additional Skills / Preferences :
Additional Information :
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 ( https : / / careers.lilly.com / us / en / workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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