Manufacturing Process Engineer – Night Shift

Elanco•Elwood, KS

9d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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.