Senior Quality Associate, Sterility Assurance

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Senior Quality Associate, Sterility Assurance

The Sterility Assurance Consultant will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices.

You will work cross-functionally to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.).

Your Responsibilities:


* Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations and ensuring adherence to regulatory requirements and industry best practices.


* Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing, media fills, and sterilization cycles.


* Identify and troubleshoot issues related to sterility assurance, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives to minimize process risks and optimize productivity.


* Develop and deliver comprehensive training programs for operators, technicians, and other relevant personnel on sterility assurance principles, best practices, and regulatory requirements.


* Ensure compliance with all applicable regulations and industry standards, prepare for and support regulatory inspections, and act as a subject matter expert during audits.

What You Need to Succeed (Minimum Qualifications):


* B.S.in related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree


* 3+ years’ experience with sterile manufacturing


* Familiarity with Global Regulatory Standards...