Sterility Assurance Scientist

Location: Triangle

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.
** Organization Overview:
** For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
** Position Brand

Description:

** Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

The Scientist/Engineer – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies.

Primary objective s include the start-up and compliant manufacturing of RTP products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the RTP site.
** Responsibilities:
*** Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
* Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
* Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk
* Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation,  airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
* Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
* Provide technical guidance to the Process Team for sterility assurance programs
* Lead or provide technical support for root cause investigations related to sterility assurance programs
* Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
* Perform periodic review of environmental monitoring data
* Lead or support risk assessments related to sterility assurance programs
* Create, execute, review, and/or approve technical documents related to sterility assurance programs
* Create, execute, and/or evaluate change controls related to sterility assurance programs
* Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
* Participate in continuous improvement projects to improve quality performance at the site
* Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed
* Support…