Your Role: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.
Your Responsibilities:- 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.
What You Need to Succeed (minimum qualifications):
- Experience: Minimum of 7-10 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 of GMP requirements within a sterile manufacturing environment.
- Communication: Strong technical writing and verbal communication skills to present complex engineering concepts to diverse stakeholders.
What will give you a competitive edge (preferred qualifications):
- Filling Experience: Hands-on experience with aseptic filling equipment, isolator technology, and vial handling systems.
- Regulatory Familiarity: Familiarity with USDA-CVB regulations for veterinary biologics and EMA / EU GMP standards.
- Automation: Experience with PLC/SCADA systems and data historians (e.g., AVEVA PI) as they relate to lyophilization monitoring.
Additional Information:- Travel: Ability and willingness to travel 0-30% (domestic and international) to support various manufacturing sites and vendor locations.
- Location: This role is based at our Global Headquarters in Indianapolis, IN.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
