Quality Assurance Advisor, 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.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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: Quality Assurance Advisor, Sterility Assurance

The Network Level Sterility Assurance Advisor provides critical oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network, ensuring manufacturing operations meet global procedures, GMP, regulatory expectations, and industry best practices.

Acting as a subject matter expert, this role involves cross-functional collaboration with production, QC, and TS/MS teams.

The primary goal is to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), contamination control, and Environmental Monitoring (EM).

 

Your Responsibilities:


* Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation.


* Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations.


* Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.


* Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.


* Provide oversight during the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including RCI and CAPA.

 

What You Need to Succeed (minimum qualifications):


* ​B.S.in engineering, microbiology/biology, or equivalent discipline. 


* 10+ years' experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning


* Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Ag...