Sterility Assurance Consultant (Information Technology)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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 Consultant
As the Sterility Assurance Consultant, you will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within our Biotech network. Your primary goal is to ensure that production and analytical processes adhere to appropriate Sterility Assurance standards, aligning with Global procedures, GMP, regulatory expectations, and industry best practices.
Your Responsibilities:
- Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations.
- Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance.
- Identify and troubleshoot issues, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives.
- Develop and deliver comprehensive training programs on sterility assurance principles, best practices, and regulatory requirements.
- Ensure compliance with all applicable regulations and industry standards, support regulatory inspections and act as a subject matter expert during audits.
What You Need to Succeed (minimum qualifications):
- Education: B.S. in a related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree.
- Experience: A minimum of 3 years' experience with sterile manufacturing.
- Top 2 skills: Familiarity with Global Regulatory Standards (FDA, EU GMP, USDA, CFIA) and experience with a variety of technologies and platforms (e.g., monoclonal antibodies, poultry vaccine technologies).
What will give you a competitive edge (preferred qualifications):
- Experience with upstream production of viruses in cell monolayers, bioreactors, and fermenters, or experience with biologicals manufacturing.
- Lean manufacturing and Six Sigma experience.
- Proven organization and time management skills to meet time-sensitive deadlines, with strong attention to detail and collaboration.
- Ability to work in a fast-paced, dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.
Additional Information:
- Travel: Domestically 15-25%
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
