CIP/SIP & Autoclave Process Engineer

amgen; Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen in North Carolina is seeking a Process Engineer for CIP/SIP/Autoclave responsibilities at our new FleX batch facility. Join the Facilities & Engineering group to design, commission, and qualify equipment for drug substance production and support startup operations.

You will work to ensure regulatory readiness, safety, and continuous improvement across manufacturing systems, collaborating with cross-functional teams and inspectors.

Qualifications

• Advanced engineering degree with biopharmaceutical knowledge preferred.
• Experience in GMP environments and regulatory processes a plus.
• Strong collaboration and leadership capabilities.

Responsibilities

• Design, build, commission, and qualify drug-substance production equipment.
• Support startup readiness and regulatory inspections.
• Develop and implement process improvements for CIP, SIP, and autoclave systems.
• Lead safety and environmental compliance efforts across site operations.

Skills

Leadership

Technical writing

Communication

Data analytics

Problem solving

Education

Master’s degree

Bachelor’s degree + 2 years engineering experience

Associate’s degree + 6 years engineering experience

High school diploma / GED + 8 years engineering experience

Tools

Data Analytics

Root Cause Analysis (RCA)

Statistical Process Control (SPC)

Six Sigma

Job description

Amgen in North Carolina is seeking a Process Engineer for CIP/SIP/Autoclave responsibilities at our new FleX batch facility. Join the Facilities & Engineering group to design, commission, and qualify equipment for drug substance production and support startup operations.

You will work to ensure regulatory readiness, safety, and continuous improvement across manufacturing systems, collaborating with cross-functional teams and inspectors.