Process Engineer (Night Shift)

Role Summary

Process Engineer (Night Shift) responsible for supporting the design, operation, control and optimization of assets supporting technical processes at Elanco’s Elwood, Kansas monoclonal antibody manufacturing facility. Subject matter expert on process and equipment, engaged in development, data analysis, troubleshooting, technology transfer, and continuous improvement. Plays a key role in day-to-day operations, change/deviation management, process improvements, and delivery of capital projects.

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.

Qualifications

• Bachelor‚Äôs 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

Preferred Qualifications

• 2+ years‚Äô 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 Requirements

• Location: Elwood, KS (60 min north of Kansas City, MO; 10 min from St. Joseph, MO)
• This is a salaried night shift position. Weekend work is required on a rotation to provide process support to ongoing operations
• Initial training may occur on day shift for a period of up to 3 to 6 months