Senior Sterility Assurance Advisor (Remote)

Elanco; Indianapolis (IN); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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

Responsabilidades

• 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.

Conhecimentos

Cross-functional collaboration

Aseptic processing

GMP knowledge

Environmental Monitoring

Formação académica

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

Ferramentas

Process validation

Descrição da oferta de emprego

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.