Sterility Assurance Advisor

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 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. 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.