Sterility Assurance Lead: Contamination Control

Elanco; Fort Dodge (IA); On-site; USD 80,000 - 110,000; Full time

Job summary

Elanco in Fort Dodge, Iowa is seeking a Sterility Assurance & Contamination Control Strategy expert. You will lead the site's contamination control strategy, ensuring compliance with global quality and regulatory standards.

This role demands a minimum of 8 years of experience in sterile manufacturing, with a strong focus on aseptic processing. Candidates with advanced degrees in microbiology or related fields and a background in regulatory interactions will have a competitive edge.

Qualifications

• 8+ years of experience in sterile manufacturing or regulated environments.
• Deep expertise in aseptic processing and sterility assurance.
• Proven ability to influence complex technical issues.

Responsibilities

• Lead design and implementation of Contamination Control Strategy.
• Oversee aseptic, process, and sterilization validation programs.
• Represent sterility assurance during regulatory inspections.

Skills

Aseptic processing

Sterility assurance

Technical oversight

Regulatory interactions

Education

Bachelor’s degree in microbiology, biology or related scientific field

Master’s or PhD in Microbiology, Immunology or related biological science

Job description

Elanco in Fort Dodge, Iowa is seeking a Sterility Assurance & Contamination Control Strategy expert. You will lead the site's contamination control strategy, ensuring compliance with global quality and regulatory standards.

This role demands a minimum of 8 years of experience in sterile manufacturing, with a strong focus on aseptic processing. Candidates with advanced degrees in microbiology or related fields and a background in regulatory interactions will have a competitive edge.