Process Engineer (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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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: Process Engineer

The Process Team Engineer is responsible for the technical support for Production operations with respect to the process, the equipment, troubleshooting, delivering capital

improvements, data analysis, regulatory compliance, as well as commissioning, qualification and validation activities across the plant site. The process team member will play a key role in reducing variability and increasing reliability.

Your Responsibilities:

• Process Improvement Project Management: Lead and execute process and equipment improvement projects, encompassing design, estimation, proposals, budgeting, and implementation, collaborating cross-functionally.

• Process Ownership & Expertise: Serve as the technical expert and asset steward for assigned processes and equipment, understanding design basis, control strategies, and potential manufacturing hazards.

• Equipment Lifecycle Management: Oversee equipment lifecycle from qualification through maintenance, including creating and approving preventative maintenance plans, utilizing statistical tools, historian charts, and root cause analysis to manage daily operations.

• Compliance & Documentation: Maintain and generate documentation adhering to cGMP, CAPA, Change Control, and other relevant regulations, including process flows, P&IDs, and equipment flow diagrams.

• Safety & Project Leadership: Champion Elanco's safety-first culture, evaluating equipment for safety concerns and acting as a subject matter expert/project manager for capital and non-capital projects.

What You Need to Succeed (minimum qualifications):

• Bachelor's degree in Engineering or equivalent experience.

• Process and Project management experience including the responsibility for troubleshooting, hands-on scoping, design, configuration, validation, deployment or maintenance.

• Prior experience working closely with manufacturing personnel to develop process control requirements.

What Will Give You the Competitive Edge (preferred qualifications):

• Experience in a fast paced cGMP working environment is a plus.

• Experience in a regulated industry such as animal health or human pharmaceutical.

• Working knowledge of applicable regulations including cGMP, FDA 21 CFR Part 11, EU Annex 11 and NEC strongly desired.

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