Lilly Scientist-TS/MS Sterility Assurance in Indianapolis, Indiana
The Scientist, Sr. Scientist, and Associate Consultant 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 develop and implement sterility assurance related initiatives, and provide technical leadership with regard to sterility assurance strategies.
Key Objectives / Deliverables:
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.
Create and review periodic review of environmental monitoring data.
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.
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.
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
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Experience with data trending and analysis
Analysis and problem solving skills
Ability to effectively influence
8 hour days – Monday through Friday
Overtime may be required
Work in a dynamic and fast-paced environment
5 – 10% Travel Required
Applicant will work in various areas within the Parenteral Site. Some allergens are present.
Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
On call rotation (by phone) may be required
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Sterility Assurance Microbiologist
Bachelors Degree in Microbiology, Biology or related scientific field
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment 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 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.
State / Province: