Scientist - TS/MS SAT (Secondary Loop)
About The Position
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. Position Brand Description: The Sr. Scientist, Principal Scientist and Sr. Principal Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS/MS – SAT) group are positions that provide support for control of the site’s manufacturing facilities. The group develops and implements sterility assurance related initiatives with regard to sterility assurance strategies.
Requirements
- Bachelors Degree in Microbiology, Biology or related scientific field (or equivalent work experience)
- Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Nice To Haves
- Experience with data trending and analysis
- Analysis and problem-solving skills
- Quality orientation
- Ability to effectively influence
Responsibilities
- Responsible for the timely execution of Environmental Monitoring, Aseptic Process Simulation, Facility Cleaning, Facility Sanitization and other Sterility Assurance programs according to procedural and global standards.
- Assists in site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
- Works cross functionally with other functions to coordinate Sterility Assurance initiatives and activities as needed.
- Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
- Lead Investigate or provide technical support for root cause investigations for sterility assurance programs.
- Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
- Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.
- Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
- Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, Environmental Monitoring protocols, and summary reports.
- Create, execute and/or review 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 regulatory audits.
- Provide content and/or data integrity reviews for regulatory submissions.
- Lead training courses related to sterility assurance programs.
Benefits
- Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
- In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
