Sterility Assurance Leader: Contamination Control Strategy

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 120,000 - 180,000; Full time

Job summary

Elanco Animal Health Incorporated in Fort Dodge, IA is seeking a senior Sterility Assurance professional to lead the site-wide Contamination Control Strategy, ensuring aseptic manufacturing excellence and regulatory readiness.

You will oversee validation programs, investigate sterility events, mentor technical staff, and drive risk-based decision-making across the organization to maintain product quality and compliance.

Qualifications

• Bachelor’s degree in microbiology or related field; advanced degree preferred.
• Minimum 8+ years in sterile manufacturing or regulated environments.
• Deep expertise in aseptic processing and sterility assurance with regulatory interactions.

Responsibilities

• Lead design, implementation, and evolution of the site-wide Contamination Control Strategy.
• Provide technical oversight for aseptic, process, and sterilization validation programs.
• Lead investigations and CAPAs for contamination events, sterility failures, deviations, and regulatory findings.
• Represent sterility assurance during regulatory inspections and corporate audits.
• Mentor and develop technical talent while driving risk-based decision-making.

Skills

Aseptic processing

Sterility assurance

Regulatory interactions

Process validation

Education

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

Advanced degree preferred

Job description

Elanco Animal Health Incorporated in Fort Dodge, IA is seeking a senior Sterility Assurance professional to lead the site-wide Contamination Control Strategy, ensuring aseptic manufacturing excellence and regulatory readiness.

You will oversee validation programs, investigate sterility events, mentor technical staff, and drive risk-based decision-making across the organization to maintain product quality and compliance.