Biopharma Process Engineer: CIP/SIP & Autoclave

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen is hiring a Process Engineer for CIP/SIP/Autoclave systems within the Facilities & Engineering group. You will design, build, commission, and qualify equipment for drug substance production, ensuring GMP compliance and lifecycle support.

You’ll support startup readiness, provide engineering assessments, and assist with capital projects and regulatory interactions. Ideal candidates bring strong engineering experience, problem solving, and collaboration skills to drive improvements and

Qualifications

• Master's degree required or equivalent combination of education and experience.
• Bachelor's degree with 2 years engineering experience or higher.
• Associates degree with 6 years engineering experience.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support site startup readiness and lifecycle support for CIP, SIP, autoclave systems.
• Coordinate with regulatory inspectors and ensure GMP compliance.
• Develop maintenance programs and coordinate spare parts.
• Participate in capital projects including procurement, construction, startup, and validation.

Skills

GMP knowledge

Data analytics

Root Cause Analysis

Project management

Team collaboration

Education

Master's degree

Bachelor's degree + 2 years engineering experience

Associates degree + 6 years engineering experience

High school diploma / GED + 8 years engineering experience

Tools

Engineering software

Job description

Amgen is hiring a Process Engineer for CIP/SIP/Autoclave systems within the Facilities & Engineering group. You will design, build, commission, and qualify equipment for drug substance production, ensuring GMP compliance and lifecycle support.

You’ll support startup readiness, provide engineering assessments, and assist with capital projects and regulatory interactions. Ideal candidates bring strong engineering experience, problem solving, and collaboration skills to drive improvements and