Senior Sterility Assurance Advisor (Remote)

Elanco Tiergesundheit AG; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Elanco seeks a Quality Assurance Advisor, Sterility Assurance, to provide technical input for aseptic and contamination control programs, collaborate across functions, and support regulatory inspections. Responsibilities include developing procedures, validating processes, and overseeing manufacturing validations and sterilization cycles.

The role emphasizes strong regulatory knowledge, problem solving, and teamwork to ensure global GMP compliance and site Sterility Assurance improvements.

Qualifications

• 10+ years' experience in parenteral, biological, or vaccine manufacturing operations
• Experience with aseptic processing and environmental monitoring
• Familiarity with FDA, EU GMP, USDA, CFIA standards

Responsibilities

• Provide technical input for Process, Aseptic, Cleaning Validation, and Contamination Control Strategy.
• Collaborate with area owners and suppliers to finalize validation/qualification requirements.
• Author and develop Elanco Functional Procedures for contamination control and aseptic processes.
• Assist in troubleshooting, gap/risk assessments, and support regulatory inspections and training.
• Provide oversight during (re)validation/qualification activities for manufacturing and sterilization cycles.

Skills

Cross-functional collaboration

Aseptic processing

GMP knowledge

Environmental Monitoring

Education

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

Tools

Process validation

Job description

Elanco seeks a Quality Assurance Advisor, Sterility Assurance, to provide technical input for aseptic and contamination control programs, collaborate across functions, and support regulatory inspections. Responsibilities include developing procedures, validating processes, and overseeing manufacturing validations and sterilization cycles.

The role emphasizes strong regulatory knowledge, problem solving, and teamwork to ensure global GMP compliance and site Sterility Assurance improvements.