Sterility Assurance Associate

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

• 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.

• B.S. in engineering, microbiology/biology, or equivalent discipline.
• Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA, EU GMP, USDA, and CFIA.

• Experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning.
• Experience with sterile manufacturing risk assessments and remediations implementation.
• Lean manufacturing and Six Sigma experience.
• Proven organization and time management skills to meet time‑sensitive deadlines, attention to detail, and collaboration in a team‑based environment.
• Ability to work in a fast‑paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

• Multiple relocation packages for eligible positions
• Two weeklong shutdowns (mid‑summer and year‑end) in the US (in addition to PTO)
• 8‑week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401(k) matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.