Manufacturing Process Engineer – 1021709 Elanco

Farmer Veteran Coalition; Kansas; Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is seeking a Manufacturing Process Engineer for our Elwood, Kansas facility. You will support design, operation, control, and optimization of processes at the monoclonal antibody manufacturing site, acting as a process expert and engaging in development, troubleshooting, technology transfer, and continuous improvement activities.

Responsibilities include on-floor technical support, ensuring equipment qualification and change control, leveraging data to optimize performance, leading

Qualifications

• Bachelor's degree in Chemical, Biological or related engineering.
• Experience in pharmaceutical, biotechnology, or a related industry.
• Working knowledge of cGMP standards and/or experience in a regulated environment, with cross-functional teams.

Responsibilities

• Provide technical and on-floor support for process and equipment, troubleshoot issues, document in the quality system, and implement corrective actions.
• Ensure equipment qualification and compliance with cGMP, Elanco policies, and regulatory requirements; oversee interventions and changes via change control.
• Leverage data to monitor performance, evaluate capacity, and identify continuous improvement opportunities; implement productivity enhancements.
• Lead and support full lifecycle of capital projects including design, development, commissioning, qualification, and validation.
• Develop and manage key technical documentation and risk mitigation strategies, including URs, P&IDs, safety assessments, and qualification protocols.

Skills

cGMP knowledge

Cross-functional teamwork

Data-driven analysis

Education

Bachelor's degree in Chemical, Biological or related engineering

Tools

SAP EAM

ERP

AutoCAD

Veeva Vault

AVEVA PI

Seeq

Meridian

Job description

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:

Manufacturing Process Engineer

The Manufacturing Process Engineer is responsible for supporting the design, operation, control and optimization of assets supporting technical processes at Elanco's Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.

The position is a subject matter expert with respect to the process and equipment and is engaged in development, data analysis, troubleshooting, technology transfer, and continuous improvement activities.

The process engineer plays a key role in day-to-day operations, change/deviation management, process improvements, and delivery of capital projects.

Your Responsibilities:

• Provide Technical and On-Floor Support for Process and Equipment: Deliver robust engineering support for both routine operations and capital projects by troubleshooting equipment and process issues, offering on-floor assistance to manufacturing teams, and ensuring that all problems are promptly documented in the quality management system. Apply thorough root cause analysis and implement appropriate corrective and preventive actions to ensure operational reliability.
• Ensure Equipment Qualification and Compliance: Maintain the qualified state of process equipment by ensuring all systems are fit for their intended use, compliant with cGMP standards, Elanco policies, and regulatory requirements. Provide oversight during interventions, maintenance, and changes, ensuring all activities are properly documented and managed through formal change control procedures.
• Drive Performance and Process Optimization Through Data Analysis: Leverage data-driven insights to monitor equipment and process performance, evaluate system capacity, and identify opportunities for continuous improvement. Recommend and implement enhancements to optimize productivity, reduce variability, and ensure consistent system control.
• Lead and Support Full Lifecycle of Capital Projects: Actively contribute to the design, development, execution, commissioning, qualification, and validation of major capital projects. This includes defining project scope, evaluating design alternatives, selecting equipment, developing user requirements, overseeing construction, and supporting process validation activities to ensure successful project delivery.
• Develop and Manage Technical Documentation and Risk Mitigation Strategies: Prepare, review, and update key documentation such as user requirement specifications, process and instrumentation diagrams (P&IDs), safety and environmental assessments, and qualification protocols. Collaborate cross-functionally to identify risks, drive value engineering, and enhance the technical and financial success of projects.

What You Need to Succeed (minimum qualifications):

• Bachelor's degree in Chemical, Biological or related engineering discipline
• Experience in pharmaceutical, biotechnology, or a related/relevant industry
• Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision with a working knowledge of cGMP standards and/or experience working in a regulated environment and success working in cross functional teams

What will give you a competitive edge (preferred qualifications):

• 2+ years' experience in pharmaceutical, biotechnology, or a related industry
• Experience in capital project design, development, and execution
• Understanding of monoclonal antibody / recombinant protein manufacturing processes
• Experience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, Meridian
• Understanding and application of RCI, FMEA and QRM tools
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics

Additional Information:

Location: Elwood, KS (60 min north of Kansas City, MO; 10 min from St. Joseph, MO)

This is a salaried day shift position.

Weekend work is required on a rotation to provide process support to ongoing operations.

Elanco Benefits and Perks

• Relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401K matching
• #LI-HL#LI-Onsite

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.