Sterility Assurance Advisor

Posted An Hour Ago
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Fort Dodge, IA, USA
In-Office
Expert/Leader
Healthtech • Pharmaceutical • Manufacturing
The Role
The Director - Sterility Assurance & Contamination Control Strategy leads contamination control strategies, oversees aseptic processes, mentors staff, and ensures compliance with global quality standards and regulations.
Summary Generated by Built In

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: Director – Sterility Assurance & Contamination Control Strategy

As Director – 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 10+ 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.

Skills Required

  • Bachelor's degree in microbiology, Biology, or related scientific field
  • Minimum 10+ years of experience in sterile manufacturing, biotechnology, or regulated environments
  • Deep expertise in aseptic processing and sterility assurance
  • Proven ability to influence complex technical issues and regulatory interactions

Elanco Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.

  • Leave & Time Off Breadth Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
  • Healthcare Strength Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
  • Retirement Support Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.

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The Company
HQ: Greenfield, Indianna
8,445 Employees

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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