Sterility Assurance Advisor

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

Sterility Assurance Advisor (Project Management)

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

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. In this role, you will be responsible for advancing contamination control strategy, strengthening sterility assurance programs, and driving innovation and risk reduction across the site.

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 Annex 1 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.

Salary Minimum: 155100Salary Maximum: 155100