Manufacturing Engineer Consultant — Process & Equipment

Kansas Ag Connection; Northern (KY); Hybrid; USD 98,000 - 150,000; Full time

Job summary

Elanco Elwood, Kansas seeks a Consultant - Manufacturing Engineer to support operation, control and optimization of manufacturing assets and processes at the Elwood monoclonal antibody facility. You will act as a subject matter expert on the process and equipment and engage in development, data analysis, troubleshooting, technology transfer, and continuous improvement.

You will participate in design, commissioning, qualification and validation activities for major projects, ensure changes comply

Qualifications

• Master's degree plus 1 year post-baccalaureate experience in job offered or related titles.
• 1 year of experience in medical device, pharma, or biotechnology industries.
• Experience with IQ, OQ, Validation, and Installation; and working in regulated environments.
• GMP documentation, SOPs, batch docs, Change Control, protocol execution, and deviation investigation.
• Statistical Process Control (SPC) to monitor process parameters and drive corrective actions.
• Design scope development and analysis for manufacturing equipment.
• Maintenance guidance for manufacturing equipment.

Responsibilities

• Support operation, control and optimization of manufacturing assets and processes at the Elwood facility.
• Serve as subject-matter expert on process and equipment; engage in development, data analysis, troubleshooting, tech transfer, and continuous improvement.
• Lead on-floor support for equipment/process issues; ensure proper CAPA and quality system entries.
• Oversee changes to keep equipment within qualified state; manage change control and validation activities.
• Contribute to design, commissioning, qualification and validation for major projects.

Skills

SPC

GMP compliance

IQ/OQ

Change Control

Deviation investigation

SOP

Quality documentation

Education

Master's degree in Engineering Management, Mechanical Engineering, a related field, or a foreign equivalent

Job description

Elanco Elwood, Kansas seeks a Consultant - Manufacturing Engineer to support operation, control and optimization of manufacturing assets and processes at the Elwood monoclonal antibody facility. You will act as a subject matter expert on the process and equipment and engage in development, data analysis, troubleshooting, technology transfer, and continuous improvement.

You will participate in design, commissioning, qualification and validation activities for major projects, ensure changes comply