Process Engineering Advisor – Lyophilization & Filling

Elanco; Indianapolis (IN); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns

8‑week parental leave

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco in Indianapolis, IN is looking for a Process Engineer specializing in Lyophilization and Filling to enhance their sterile manufacturing processes, focusing on vaccines.

The successful candidate will lead the design and optimization of critical equipment, ensuring compliance with regulatory standards and operational efficiency. Applicants should have 7-10 years of experience in process engineering and strong communication skills.

Elanco offers various employee benefits, including relocation packages and flexible work arrangements.

Qualifications

• 7-10 years of experience in process engineering within the relevant industry.
• Technical expertise in design and operation of industrial scale lyophilizers.
• Strong understanding of GMP requirements for sterile manufacturing.

Responsibilities

• Lead design and commissioning of lyophilization and filling equipment.
• Develop and optimize lyophilization cycles for product stability.
• Provide technical oversight for freeze dryer operation and maintenance.
• Ensure compliance with GMPs and quality standards.
• Support regulatory filings and inspections for sterile processes.
• Collaborate with R&D, Quality Assurance, and Operations for product transition.

Skills

Process engineering

Lyophilization

Filling operations

GMP compliance

Technical writing

Collaboration

Education

Bachelor's or Master’s degree in Chemical Engineering

Tools

PLC/SCADA systems

Data historians (e.g., AVEVA PI)

Job description

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.

Elanco Benefits and Perks

• 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

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.