Sterility Assurance Advisor
Elanco
August 15, 2026
On-site
Fort Dodge, IA
Operations
Your Role: Sterility Assurance & Contamination Control Strategy
As Sterility Assurance & Contamination Control Strategy, you will serve as the site’s technical authority for contamination control and sterility assurance, ensuring alignment with global quality standards and regulatory expectations. Advance contamination control strategy, strengthen sterility assurance programs, and drive innovation and risk reduction across the site.
Responsibilities:
- Lead the design, implementation, and continuous evolution of the site-wide Contamination Control Strategy (CCS)
- Provide technical oversight and strategic direction for aseptic, process, and sterilization validation programs
- Lead investigations and resolution of contamination events, sterility failures, deviations, and CAPAs
- Represent and defend sterility assurance programs during regulatory inspections and corporate audits
- Mentor and develop technical talent while driving scientific rigor and risk-based decision-making
Minimum qualifications:
- Education: Bachelor’s degree in microbiology, biology, or related scientific field (advanced degree preferred)
- Experience: 8+ years in sterile manufacturing, biotechnology, or related regulated environments
- Skills: Deep expertise in aseptic processing and sterility assurance; ability to influence complex technical issues and regulatory interactions
Preferred qualifications:
- Master’s or PhD in Microbiology, Immunology, or related biological science
- Experience with virus production in cell monolayers, bioreactors, or fermenters
- Knowledge of microbial ecology and sterile manufacturing environments
- Experience with EU GMP Annex 1 requirements and CCS program implementation
- Experience leading large-scale quality, validation, or contamination control initiatives in regulated environments
As Sterility Assurance & Contamination Control Strategy, you will serve as the site’s technical authority for contamination control and sterility assurance, ensuring alignment with global quality standards and regulatory expectations. Advance contamination control strategy, strengthen sterility assurance programs, and drive innovation and risk reduction across the site.
Responsibilities:
- Lead the design, implementation, and continuous evolution of the site-wide Contamination Control Strategy (CCS)
- Provide technical oversight and strategic direction for aseptic, process, and sterilization validation programs
- Lead investigations and resolution of contamination events, sterility failures, deviations, and CAPAs
- Represent and defend sterility assurance programs during regulatory inspections and corporate audits
- Mentor and develop technical talent while driving scientific rigor and risk-based decision-making
Minimum qualifications:
- Education: Bachelor’s degree in microbiology, biology, or related scientific field (advanced degree preferred)
- Experience: 8+ years in sterile manufacturing, biotechnology, or related regulated environments
- Skills: Deep expertise in aseptic processing and sterility assurance; ability to influence complex technical issues and regulatory interactions
Preferred qualifications:
- Master’s or PhD in Microbiology, Immunology, or related biological science
- Experience with virus production in cell monolayers, bioreactors, or fermenters
- Knowledge of microbial ecology and sterile manufacturing environments
- Experience with EU GMP Annex 1 requirements and CCS program implementation
- Experience leading large-scale quality, validation, or contamination control initiatives in regulated environments