Process Engineer, Biologics Manufacturing

Elanco•Elwood, KS

1d•Onsite

About The Position

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: Process Engineer, Biologics Manufacturing The Process Engineer is responsible for supporting the operation, control, and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) facility. This role serves as a subject matter expert in both process and equipment performance, contributing to development, data analysis, troubleshooting, technology transfer, and continuous improvement initiatives. In this role, you will play a key part in day-to-day manufacturing operations while also supporting local and large-scale capital projects, including equipment design, installation, commissioning, qualification, and validation—helping drive the future of biologics manufacturing at the site.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field
5+ years of experience in pharmaceutical, biotechnology, or a related industry in a similar role
Strong analytical thinking and problem-solving skills
Working knowledge of cGMP standards or experience in a regulated environment
Ability to work effectively in cross-functional teams
Strong communication, organizational, and technical skills

Nice To Haves

Experience supporting capital projects (design, commissioning, validation)
Knowledge of monoclonal antibody or biologics manufacturing processes
Experience with systems such as SAP, AutoCAD, Veeva, or other ERP/QMS tools
Familiarity with risk and root cause methodologies (FMEA, RCI, QRM)
Understanding of USDA, FDA, or EU GMP regulations for biologics

Responsibilities

Process & Equipment Support: Provide technical expertise and engineering solutions for process and equipment-related challenges. Support manufacturing operations on the floor by troubleshooting issues and ensuring reliable performance.
Operational Excellence & Compliance: Ensure processes and equipment operate in a controlled, compliant state aligned with cGMP standards and regulatory expectations. Support investigations, root cause analysis, and implementation of CAPA.
Data Analysis & Continuous Improvement: Utilize data-driven insights to monitor performance, identify variability, and implement improvements that enhance efficiency, throughput, and process robustness.
Project Engineering & Capital Execution: Support the full lifecycle of capital projects, including design, installation, commissioning, qualification, and validation of equipment and systems.
Change Management & Documentation: Ensure all changes to processes and equipment are properly assessed, documented, and executed through change control systems. Maintain and review technical documentation such as process flows, specifications, and validation protocols.
Cross-Functional Collaboration: Partner with Manufacturing, Quality, Engineering, and other teams to resolve technical challenges, mitigate risks, and drive successful project outcomes.