TS/MS SAT – Secondary Loop Associate Steward

Lilly•Indianapolis, IN

1d•Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, with employees working to discover and bring life-changing medicines, improve disease understanding, and contribute to communities through philanthropy and volunteerism. The Sr. Scientist, Principal Scientist and Sr. Principal Scientist positions within the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS/MS – SAT) group are responsible for providing technical leadership and support for controlling the site’s manufacturing facilities. This group develops and implements sterility assurance related initiatives and strategies.

Requirements

Bachelors Degree in Microbiology, Biology or related scientific field (or equivalent work experience)
Minimum of 3 years pharmaceutical or related experience

Nice To Haves

Experience with data trending and analysis
Analysis and problem-solving skills
Quality orientation
Ability to effectively influence

Responsibilities

Sterility Assurance program expert responsible for troubleshooting and resolution of issues in area of responsibility
Responsible for the coordination of the escalation model with management and stewards, as this role is the first point of escalation after the Process Team.
Ensures the execution of Environmental Monitoring, Aseptic Process Simulation, Facility Cleaning, Facility Sanitization and other sterility assurance programs for area of responsibility and that they are aligned with global standards.
Participate in our self-inspection program, in regards to Sterility Assurance, including communication of observations and recommendations for continuous improvement to manufacturing and support personnel for area of responsibility.
Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
Create and evaluate the review of annual environmental monitoring data in addition to other sterility assurance periodic data reviews as needed
Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, Environmental Monitoring protocols, and summary reports as needed.
Create, execute and/or help coordinate change controls related to sterility assurance programs and continuous improvement projects to improve quality performance at the site.
Investigate and/or provide technical support concerning issues of medium criticality impacting 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.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
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.

Benefits

Company bonus (depending, in part, on company and individual performance)
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)