Bioprocess Engineer (Entry Level)

Job Description

At Elanco, it all starts with animals! As a global leader in animal health, we are dedicated to innovation and to delivering products and services that prevent and treat disease in farm animals and pets. We’re driven by our vision of “Food and Companionship Enriching Life” and our commitment to sustainability—embodied in the Elanco Healthy Purpose™—to advance the health of animals, people, the planet, and our enterprise. At Elanco, we take pride in fostering a diverse and inclusive work environment, believing that diversity fuels innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, working with dynamic individuals, and acquiring new skills and experiences that will elevate your career. Making animals’ lives better makes life better—join our team today!

Requirements

• B.S. in engineering, microbiology/biology, or equivalent discipline.
• Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA, EU GMP, USDA, and CFIA.

Responsibilities

• Provide technical and SME input in Process Validation, Aseptic Validation, Cleaning Validation and Contamination Control Strategy.
• Work closely with area owners and suppliers to finalize validation/qualification requirements for facility, process, equipment, and systems.
• Assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.
• Provide oversight during execution of (re)validation/qualification of product manufacturing, aseptic processing, media holds, and sterilization cycles.
• Support corrective actions including investigating and ensuring proper RCI and CAPA definition/effectiveness in resolving deviations related to sterility assurance.