Scientist TS/MS Sterility Assurance Technology
Company: Eli Lilly
Posted on: August 7, 2022
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 35,000 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. 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: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 /
- 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
- Create and review periodic review of environmental monitoring
- 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
- 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
- Participate in continuous improvement projects to improve
quality performance at the site.
- Participate or provide guidance for sterility assurance
programs during regulatory audits.Basic Qualifications:
- Bachelors Degree in Microbiology, Biology or related STEM
- Experience with data trending and analysis
- Analysis and problem solving skills
- Quality orientation
- Ability to effectively influence
- Responsible for maintaining a safe work environment, working
safely and accountable for supporting all HSE Corporate and Site
- Understanding of GMPs and applicable internal standards
- Communication (oral and written) skills; technical writing
- Teamwork / interpersonal skillsOther Information:
- 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
- On call rotation (by phone) may be requiredEli Lilly and
Company, Lilly USA, LLC and our wholly owned subsidiaries
(collectively "Lilly") are committed to help individuals with
disabilities to participate in the workforce and ensure equal
opportunity to compete for jobs. If you require an accommodation to
submit a resume for positions at Lilly, please email Lilly Human
Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for
further assistance. Please note This email address is intended for
use only to request an accommodation as part of the application
process. Any other correspondence will not receive a response.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. 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.
As a condition of employment with Eli Lilly and Company and its
subsidiaries in the United States and Puerto Rico, you must be
fully COVID-19 vaccinated and provide proof of vaccination
satisfactory to the company (subject to applicable law).
Keywords: Eli Lilly, Indianapolis , Scientist TS/MS Sterility Assurance Technology, IT / Software / Systems , Fairland, Indiana
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