Manufacturing Engineer Consultant – GMP & Process Optimization

Elanco

Kansas

On-site

USD 98,000 - 150,000

Full time

14 days+

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Job summary

Elanco is seeking a Consultant – Manufacturing Engineer for the Elwood, Kansas facility. You will support operations, provide SME input on processes and equipment, and drive improvements through data-driven analysis and robust change control.

This role requires hands-on troubleshooting, qualification activities, and adherence to cGMP standards. The position emphasizes collaboration with manufacturing teams, capital project execution, and ensuring regulatory compliance while delivering

Qualifications

1 year of experience in medical device, pharma, or biotechnology industries.
Experience in Installation Qualification (IQ), Operational Qualification (OQ), Validation and commissioning.
cGMP standards with experience in a regulated environment.
GMP documentation, SOPs, Batch Documents, Change Control, protocol execution, and deviation investigations.
Statistical Process Control (SPC) to monitor and control process parameters.
Development and analysis of design scope for manufacturing equipment.
Maintenance guidance for manufacturing equipment.

Responsibilities

Support operation and optimization of manufacturing assets at the Elwood, KS monoclonal antibody facility.
Act as SME for processes and equipment; contribute to capital projects and validations.
Provide on-floor support for equipment and process troubleshooting.
Ensure changes and interventions are documented and do not compromise qualified state; oversee maintenance.
Use data-driven analysis to improve system performance and capacity.