Manufacturing Process Engineer — Continuous Improvement

Amgen Inc. (IR); New Albany, Northern (OH, KY); Hybrid; USD 108,000 - 146,000; Full time

Job summary

Amgen seeks a Specialist, Manufacturing to support execution of manufacturing and quality systems, including continuous improvement, technology transfer, and process validation. The role requires applying scientific expertise, and participating in risk assessments, training, and non-conformance handling to ensure quality and compliance.

The candidate will serve as a primary production process owner for select systems and contribute to process ownership responsibilities across operations, with

Qualifications

• Doctorate degree or equivalent professional qualifications in engineering, manufacturing, packaging or quality.
• Extensive experience in pharmaceutical/biotech manufacturing environments.
• Experience across engineering, manufacturing, and quality domains.

Responsibilities

• Apply process expertise and manage manufacturing procedures reflecting current operations.
• Assess process performance and implement improvements.
• Support training materials and provide technical training as needed.
• Coordinate technology transfer, NPI, and process modifications.
• Support non-conformance investigations, CAPA closures, and risk evaluations.
• Assist with process validation protocols and regulatory inspections.
• Participate in change control and CCRB assessments.

Education

Doctorate degree

Master’s degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Bachelor’s degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Associate’s degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Job description

Amgen seeks a Specialist, Manufacturing to support execution of manufacturing and quality systems, including continuous improvement, technology transfer, and process validation. The role requires applying scientific expertise, and participating in risk assessments, training, and non-conformance handling to ensure quality and compliance.

The candidate will serve as a primary production process owner for select systems and contribute to process ownership responsibilities across operations, with