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 Agriculture), and CFIA (Canadian Food Inspection Agency)

What Will Give You the Competitive Edge (preferred qualifications):

• Masters or PhD preferred.

• Lean manufacturing and six sigma experience.

• Experience with sterile manufacturing risk assessments and remediations implementation.

• Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.

• Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

• Remote position with occasional travel (up to 30%)

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!