Process Engineering Advisor – Lyophilization & Filling

Elanco in; Indianapolis (IN); Sur place; USD 138 000 - 168 000; Plein temps

Avantages offerts par ce poste

Relocation packages

Annual bonus

Flexible work arrangements

6% 401K matching

Résumé du poste

Elanco is seeking a Process Engineering Advisor based at our Global Headquarters in Indianapolis, IN, focusing on Lyophilization and Filling to strengthen sterile vaccine production globally. You will drive robust design, efficient operation, and continuous improvement across the manufacturing network.

The role requires 7–10 years of process engineering experience, expertise in lyophilization and filling, and strong GMP knowledge.

Qualifications

• 7–10 years in process engineering in pharma/animal health
• Bachelor's or Master's in Chemical/Mechanical/Bioengineering or related field
• Experience with lyophilizers, design, qualification, operation
• Strong GMP/regulatory knowledge for sterile manufacturing
• Strong technical writing and verbal communication skills

Responsabilités

• Lead the design, qualification, and commissioning of lyophilization systems and filling equipment for global vaccine production
• Develop and optimize lyophilization cycles to ensure product stability, quality, and efficiency
• Provide technical oversight for operation and maintenance of freeze dryers across sites
• Ensure all engineering activities and documentation comply with GMPs and internal quality standards
• Support regulatory filings and inspections with technical documentation
• Collaborate with R&D, QA, and Site Operations to transition products to commercial manufacturing

Connaissances

Process engineering

Lyophilization

GMP compliance

Technical writing

Formation

Bachelors/Masters in Engineering

Outils

PLC/SCADA

AVEVA PI

Description du poste

Process Engineering Advisor – Lyophilization & Filling (Project Management)

At Elanco (NYSE: ELAN) – it all starts with animals!

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!

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 of7-10 years of experiencein 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.

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 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.

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

• 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Salary Minimum: 153000Salary Maximum: 153000