Summary

Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.

Job description

Your day-to-day will include:

Responsible for supporting the operation, control, and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) facility.
Serve as a subject matter expert in both process and equipment performance, contributing to development, data analysis, troubleshooting, technology transfer, and continuous improvement initiatives.
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.
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.

You have the following technical skills and qualifications:

Requirement – Bachelor’s degree in Life Sciences, Electrical Engineering, Industrial Engineering, Mechanical Engineering, a related field, or a foreign equivalent plus 3 years progressively responsible post-baccalaureate experience in job offered or any engineering related roles.
Relevant experience – Applicants must have 3 years of experience in the following: (1) Working in pharmaceutical, biotechnology, or a related industry; (2) cGMP standards and experience working in a regulated environment; (3) aseptic processing techniques and cleaning/sanitization methodologies; (4) Process Validation, completing risk assessments (FMEA), and Process Performance Qualifications (PPQ); (5) interpreting and complying with USDA/FDA/EMA regulations; (6) utilizing statistical tools to analyze process trends, identify deviations, and determine corrective actions (CAPA); and (7) operating and maintaining Single-Use Bioreactor Systems, SCADA, and MES (Manufacturing Execution Systems).

Requirements

Bachelor’s degree in Life Sciences, Electrical Engineering, Industrial Engineering, Mechanical Engineering, a related field, or a foreign equivalent
3 years progressively responsible post-baccalaureate experience in job offered or any engineering related roles
3 years of experience working in pharmaceutical, biotechnology, or a related industry
3 years of experience with cGMP standards and working in a regulated environment
3 years of experience with aseptic processing techniques and cleaning/sanitization methodologies
3 years of experience with Process Validation, completing risk assessments (FMEA), and Process Performance Qualifications (PPQ)
3 years of experience interpreting and complying with USDA/FDA/EMA regulations
3 years of experience utilizing statistical tools to analyze process trends, identify deviations, and determine corrective actions (CAPA)
3 years of experience operating and maintaining Single-Use Bioreactor Systems, SCADA, and MES (Manufacturing Execution Systems)

Company overview

Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.