Process Engineering Advisor – Lyophilization & Filling
About The Position
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.
Requirements
- Minimum of 7-10 years of experience in process engineering within the pharmaceutical, biotechnology, or animal health industry.
- Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Bioengineering, or a related technical field.
- Proven experience in the design, qualification, and operation of industrial scale lyophilizers.
- Deep understanding of GMP requirements within a sterile manufacturing environment.
- Strong technical writing and verbal communication skills to present complex engineering concepts to diverse stakeholders.
Nice To Haves
- Hands-on experience with aseptic filling equipment, isolator technology, and vial handling systems.
- Familiarity with USDA-CVB regulations for veterinary biologics and EMA / EU GMP standards.
- Experience with PLC/SCADA systems and data historians (e.g., AVEVA PI) as they relate to lyophilization monitoring.
Responsibilities
- Lead the design, selection, and commissioning of lyophilization (freeze-drying) systems and filling equipment for global vaccine production.
- Develop and optimize lyophilization cycles to ensure product stability, quality, and manufacturing efficiency.
- Provide technical oversight for the operation and maintenance of freeze dryers, troubleshooting complex mechanical and process issues at various global sites.
- Ensure all engineering activities and documentation comply with GMPs and Elanco internal quality standards.
- Support regulatory filings and inspections, providing technical documentation and expertise for sterile manufacturing processes.
- Work closely with R&D, Quality Assurance, and Site Operations to transition new products into commercial manufacturing globally.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
