Process Engineering Advisor – Lyophilization & Filling

Process Engineering Advisor – Lyophilization & Filling (Project Management)

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!

Elanco Animal Health is seeking a highly skilled Process Engineer specializing in Lyophilization and Filling to join our Global Engineering team. Based at our Global Headquarters in Indianapolis, IN, this role is critical in ensuring the robust design, efficient operation, and continuous improvement of our sterile manufacturing processes globally, with a primary focus on vaccine manufacturing. The successful candidate will provide technical expertise in freeze-drying technology and filling operations, ensuring all processes meet stringent quality and regulatory standards across our international manufacturing network.

• Equipment Design & Specification:Lead the design, selection, and commissioning of lyophilization (freeze-drying) systems and filling equipment for global vaccine production.
• Process Optimization:Develop and optimize lyophilization cycles to ensure product stability, quality, and manufacturing efficiency.
• Operational Support:Provide technical oversight for the operation and maintenance of freeze dryers, troubleshooting complex mechanical and process issues at various global sites.
• Compliance & Quality:Ensure all engineering activities and documentation comply with GMPs and Elanco internal quality standards.
• Regulatory Support:Support regulatory filings and inspections, providing technical documentation and expertise for sterile manufacturing processes.
• Cross-Functional Collaboration:Work closely with R&D, Quality Assurance, and Site Operations to transition new products into commercial manufacturing globally.

• Experience:Minimum of7-10 years of experience
  in process engineering within the pharmaceutical, biotechnology, or animal health industry.
• Education:Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Bioengineering, or a related technical field.
• Technical Expertise:Proven experience in the design, qualification, and operation of industrial scale lyophilizers.
• Regulatory Knowledge:Deep understanding ofGMPrequirements within a sterile manufacturing environment.
• Communication:Strong technical writing and verbal communication skills to present complex engineering concepts to diverse stakeholders.

• Filling
  
  Experience:
  
  Hands-on experience with aseptic filling equipment, isolator technology, and vial handling systems.
• Regulatory Familiarity:Familiarity withUSDA-CVBregulations for veterinary biologics andEMA / EU GMPstandards.
• Automation:Experience with PLC/SCADA systems and data historians (e.g., AVEVA PI) as they relate to lyophilization monitoring.

• Travel:Ability and willingness to travel 0-30%(domestic and international) to support various manufacturing sites and vendor locations.
• Location:This role is based…