Process Engineer (Night Shift)

Role Summary

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

Responsibilities

• Provide Technical and On-Floor Support for Process and Equipment: troubleshoot issues, assist manufacturing teams, document problems in the quality management system, perform root cause analysis, and implement corrective/preventive actions.
• Ensure Equipment Qualification and Compliance: maintain qualification of process equipment, ensure regulatory and policy compliance, oversee interventions, maintenance, and changes with formal change control documentation.
• Drive Performance and Process Optimization Through Data Analysis: monitor performance, evaluate capacity, identify improvements, and implement enhancements to optimize productivity and control.
• Lead and Support Full Lifecycle of Capital Projects: contribute to design, development, execution, commissioning, qualification, validation, and process validation; define scope, evaluate options, select equipment, develop user requirements, oversee construction.
• Develop and Manage Technical Documentation and Risk Mitigation Strategies: prepare and review URS, P&IDs, safety/environmental assessments, qualification protocols; collaborate cross-functionally to identify risks and drive value engineering.

Qualifications

• Required: Bachelor‚Äôs degree in Chemical, Biological or related engineering discipline
• Required: Experience in pharmaceutical, biotechnology, or related industry
• Required: Self-motivated team player with ability to work with minimal supervision, knowledge of cGMP standards or experience in a regulated environment, and success working in cross-functional teams
• Preferred: 2+ years in pharmaceutical/biotech industry
• Preferred: Experience in capital project design, development, and execution
• Preferred: Understanding of monoclonal antibody/recombinant protein manufacturing processes
• Preferred: Experience with SAP EAM/ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, Meridian
• Preferred: Understanding and application of RCI, FMEA and QRM tools
• Preferred: Working knowledge of USDA and/or EU GMP regulations for veterinary biologics

Skills

• Data analysis and problem-solving
• Process understanding and technical documentation
• Root cause analysis and CAPA implementation
• Project management and cross-functional collaboration
• Regulatory compliance and quality management systems

Education

• Bachelor‚Äôs degree in Chemical, Biological or related engineering discipline

Additional Requirements

• Location: Elwood, KS
• Salaried night shift; weekend work on a rotation to support ongoing operations
• Initial training may occur on day shift for up to 3‚Äì6 months