CIP/SIP & Autoclave Process Engineer

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen Inc. is seeking a Process Engineer focused on CIP, SIP, and autoclave systems to join the Facilities & Engineering group. You will help design, commission, qualify, and validate manufacturing equipment for drug substance production, ensuring regulatory compliance and readiness for startup.

The role emphasizes hands-on troubleshooting, lifecycle support for CIP/SIP systems, and collaboration with regulatory inspectors to maintain GMP standards. Domestic travel may be required.

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or similar with 3+ years in biopharma ops.

Responsibilities

• Support commissioning, qualification, startup readiness and validation of CIP/SIP/autoclave systems.

Skills

Data analytics

Root cause analysis

Six Sigma

GMP knowledge

Leadership

Communication

Education

Master's degree in Engineering

Bachelor's degree in Chemical or Mechanical Engineering

Tools

CIP/SIP systems

Autoclaves

Process equipment troubleshooting

Job description

Amgen Inc. is seeking a Process Engineer focused on CIP, SIP, and autoclave systems to join the Facilities & Engineering group. You will help design, commission, qualify, and validate manufacturing equipment for drug substance production, ensuring regulatory compliance and readiness for startup.

The role emphasizes hands-on troubleshooting, lifecycle support for CIP/SIP systems, and collaboration with regulatory inspectors to maintain GMP standards. Domestic travel may be required.