Sterility Assurance Advisor

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

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your Role:

Sterility Assurance & Contamination Control Strategy

Your 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 across the organization

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree in microbiology, Biology, or related scientific field; advanced degree preferred
• Experience: Minimum 8+ years of experience in sterile manufacturing, biotechnology, or related regulated environments
• Top 2 skills: Deep expertise in aseptic processing and sterility assurance combined with proven ability to influence complex technical issues and regulatory interactions

What will give you a competitive edge (preferred qualifications):

• Master’s or PhD in Microbiology, Immunology, or related biological science
• Experience with virus production in cell monolayers, bioreactors, or fermenters
• Strong knowledge of microbial ecology and sterile manufacturing environments
• Experience with EU GMP Annex1 requirements and implementation of CCS programs
• Experience leading large-scale quality, validation, or contamination control initiatives across regulated environments

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.