Manufacturing Process Engineer

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

401K matching

Job summary

Elanco– manufacturing process engineer role at the Elwood, Kansas monoclonal antibody facility, supporting design, operation, control and optimization of processes and equipment. This position provides on-floor technical support, ensures cGMP compliance, and leads change control and data-driven improvements.

The role covers lifecycle management of capital projects, process validation activities, and development of technical documentation while collaborating across functions to deliver reliable,

Qualifications

• Bachelor’s degree in Chemical, Biological or related engineering discipline.
• Experience in pharmaceutical, biotechnology, or a related industry.
• Self-motivated team player with ability to work with minimal supervision in a regulated environment.
• Knowledge of cGMP standards and/or experience in regulated environments.

Responsibilities

• Provide Technical and On-Floor Support for Process and Equipment: troubleshoot issues, support manufacturing teams, document in QMS.
• Ensure Equipment Qualification and Compliance: keep systems qualified and document interventions through change control.
• Drive Performance and Process Optimization Through Data Analysis: monitor performance, identify opportunities for improvement.
• Lead and Support Full Lifecycle of Capital Projects: design, develop, execute, commissioning, qualification, and validation of capital projects.
• Develop and Manage Technical Documentation and Risk Mitigation Strategies: prepare and review URS, P&IDs, safety assessments, qualification protocols.

Skills

cGMP knowledge

Data-driven decision making

Cross-functional collaboration

Process optimization

Project execution

Education

Bachelor’s degree in Chemical/Biological 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 EngineerThe 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 disciplineExperience in pharmaceutical, biotechnology, or a related/relevant industrySelf-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 teamsWhat will give you a competitive edge (preferred qualifications):2+ years’ experience in pharmaceutical, biotechnology, or a related industryExperience in capital project design, development, and executionUnderstanding of monoclonal antibody / recombinant protein manufacturing processesExperience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, MeridianUnderstanding and application of RCI, FMEA and QRM toolsWorking knowledge of USDA and/or EU GMP regulations for veterinary biologicsAdditional 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.Don’t meet every single requirement? Studies have shown under-represented 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 PerksWe offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:Relocation packages8-week parental leave9 Employee Resource GroupsAnnual bonus offeringUp to 6% 401K matching#LI-HL#LI-OnsiteElanco 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 statusElanco 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.