TS/MS SAT – Secondary Loop Associate Steward

Eli Lilly and Company • Us, IN

3d • 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 provide technical leadership and support for controlling the site’s manufacturing facilities. This group is responsible for developing and implementing sterility assurance related initiatives and strategies. The Associate Steward role is a sterility assurance program expert, coordinating escalation models, ensuring execution of various sterility assurance programs, providing technical guidance, and participating in continuous improvement and regulatory audit support.

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)
• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees