Scientist - TS​/MS - Sterility Assurance Technology

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.

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 39,000 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. #We Are Lilly

The 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 and provides technical leadership with regard to sterility assurance strategies.

• 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 Flow level.
• Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
• Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
• Lead 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.
• Lead site aseptic self‑inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
• 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, justification documents, 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.

• Bachelor’s degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience.

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Understanding of GMPs and applicable internal standards
• Parenteral Manufacturing experience
• Communication (oral and written) skills; technical writing skills
• Teamwork / interpersonal skills
• Experience with data trending and analysis
• Analysis and problem solving skills
• Quality orientation
• Ability to effectively influence

• 8 hour days – Monday through Friday
• Overtime…