Biotech Manufacturing Process Engineer — Capital Projects

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

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,