Remote Sterility Assurance Expert

Elanco Tiergesundheit AG; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns in the US

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco Animal Health seeks a Senior Quality Assurance Advisor specializing in Sterility Assurance to oversee aseptic processing and contamination control within the Biotech network. You will collaborate across production, QC and TS/MS to enhance sterility programs and ensure compliance with global GMP standards.

Responsibilities include developing procedural controls, validation oversight, and supporting regulatory inspections while guiding teams through remediation and risk mitigation in a

Qualifications

• BS in engineering, microbiology/biology or equivalent discipline.
• 10+ years in parenteral, biological, or vaccine manufacturing operations.
• Familiarity with FDA, EU GMP, USDA and CFIA regulations.

Responsibilities

• Provide SME input for Process, Aseptic, Cleaning Validation and Contamination Control programs.
• Collaborate to finalize validation/qualification requirements for facilities, processes, equipment and systems.
• Author Elanco Functional Procedures for contamination control and aseptic processes.
• Assist in troubleshooting, gap/risk assessments and regulatory inspections training.
• Oversee (re)validation/qualification activities for manufacturing and sterilization cycles; support CAPA.

Skills

Sterility Assurance

Aseptic Processing

Environmental Monitoring

Contamination Control

Process Validation

Regulatory Compliance

GMP

CAPA

Training

Education

B.S. in engineering, microbiology/biology

Job description

Elanco Animal Health seeks a Senior Quality Assurance Advisor specializing in Sterility Assurance to oversee aseptic processing and contamination control within the Biotech network. You will collaborate across production, QC and TS/MS to enhance sterility programs and ensure compliance with global GMP standards.

Responsibilities include developing procedural controls, validation oversight, and supporting regulatory inspections while guiding teams through remediation and risk mitigation in a