Sterility Assurance & Contamination Control Lead

Elanco in; Fort Dodge (IA); On-site; USD 140,000 - 171,000; Full time

Job summary

Elanco is seeking a Sterility Assurance Advisor to lead contamination control and sterility programs at the site level. You will provide technical direction for aseptic processes and validation, and champion risk-based decisions to improve regulatory readiness.

The role requires extensive experience in sterile manufacturing and a deep understanding of industry standards, with the aim of sustaining quality, compliance, and innovation across the site.

Qualifications

• Bachelor's degree in microbiology or related field; advanced degree preferred.
• Minimum 8+ years of experience in sterile manufacturing, biotechnology, or related regulated environments.
• Deep expertise in aseptic processing and sterility assurance with ability to influence complex technical issues and regulatory interactions.

Responsibilities

• Lead design, implementation, and evolution of the site-wide Contamination Control Strategy (CCS).
• Provide technical oversight for aseptic, process, and sterilization validation programs.
• Lead investigations and CAPAs for contamination events and sterility issues.
• Represent sterility assurance programs during regulatory inspections and audits.
• Mentor technical staff and promote risk-based decision making.

Skills

Aseptic processing

Sterility assurance

Regulatory interactions

Education

Bachelor's degree in microbiology or related field

Job description

Elanco is seeking a Sterility Assurance Advisor to lead contamination control and sterility programs at the site level. You will provide technical direction for aseptic processes and validation, and champion risk-based decisions to improve regulatory readiness.

The role requires extensive experience in sterile manufacturing and a deep understanding of industry standards, with the aim of sustaining quality, compliance, and innovation across the site.