Senior Process Engineer - CIP/SIP & Autoclave Systems

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, focusing on CIP, SIP, and Autoclave systems for drug substance production. You will design, commission, and qualification activities, partnering with corporate engineering to ensure GMP compliance and reliable operations.

This role requires advanced engineering degrees or extensive equivalent experience, with a track record in biopharmaceutical manufacturing and project leadership.

Qualifications

• Doctorate degree or equivalent engineering experience required.
• Master’s degree with 2 years of engineering experience.
• Bachelor’s degree with 4 years of engineering experience.
• Associate’s degree with 8 years of engineering experience.
• High school diploma with 10 years of engineering experience.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, and related automation.
• Lead commissioning, qualification runs and troubleshooting to ensure GMP compliance.
• Support 24/7 operation readiness and on-call coverage.

Skills

Leadership

Communication

Technical writing

Presentation skills

Education

Doctorate degree

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree in Engineering

High school diploma / GED

Job description

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, focusing on CIP, SIP, and Autoclave systems for drug substance production. You will design, commission, and qualification activities, partnering with corporate engineering to ensure GMP compliance and reliable operations.

This role requires advanced engineering degrees or extensive equivalent experience, with a track record in biopharmaceutical manufacturing and project leadership.