Manufacturing Process Engineer – Night Shift

Manufacturing Process Engineer – Night Shift

The Manufacturing Process Engineer – Night Shift is responsible for supporting the design, operation, control and optimization of assets that support technical processes at Elanco’s Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The role requires subject‑matter expertise in process and equipment, and involves 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 the delivery of capital projects.

• Provide Technical and On‑Floor Support for Process and Equipment: Deliver robust engineering support for routine operations and capital projects by troubleshooting equipment and process issues, offering on‑floor assistance to manufacturing teams, and ensuring all problems are promptly documented in the quality management system. Apply root‑cause analysis and implement 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 Life Cycle 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.

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 capable of working, prioritizing and delivering results with minimal supervision, with a working knowledge of cGMP standards and/or experience in a regulated environment and success working in cross‑functional teams.

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.

• Location:
  
  Elwood, KS (60 min north of Kansas City, MO; 10 min from St. Joseph, MO).
• Shift
  
  Schedule:
  
  Approximately 5:30pm – 2:00am. Weekend work is required on a rotation to provide process support to ongoing operations.

• Relocation packages.
• Two‑week shutdowns (mid‑summer and year‑end) in the US (in addition to PTO).
• 8‑week parental leave.
• 9 Employee Resource Groups.
• Annual bonus offering.
• Up to 6% 401(k) matching.

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.