Biopharma Process Engineer: CIP/SIP & Autoclave

Amgen SA; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plans

Job summary

Amgen in Holly Springs, NC is seeking a Process Engineer (CIP/SIP/Autoclave) to join the Facilities & Engineering group. You will design, build, commission, and qualify new equipment for drug substance production and develop domain expertise to support operations at start-up.

Responsibilities include commissioning and qualification of manufacturing systems per GMP, lifecycle support for CIP/SIP/autoclave systems, and collaboration with regulatory inspectors to ensure compliance and continuous

Qualifications

• Master’s degree in engineering.
• (OR) Bachelor’s degree in Chemical or Mechanical Engineering with relevant experience.
• 2+ years of engineering experience or 6+ years with an Associate’s degree.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support commissioning, qualification, startup readiness, and routine manufacturing operations.
• Develop lifecycle support for CIP, SIP, autoclave systems and related automation.
• Ensure safety and regulatory compliance during operations and inspections.

Skills

CIP systems

SIP circuits

Autoclaves

GMP compliance

Regulatory interaction

Root Cause Analysis

Education

Master’s degree in Engineering

Bachelor’s degree in Chemical or Mechanical Engineering

Associate’s degree with 6+ years of experience

High school diploma / GED with 8+ years of Engineering experience

Tools

Automation platforms

HMI/SCADA

Job description

Amgen in Holly Springs, NC is seeking a Process Engineer (CIP/SIP/Autoclave) to join the Facilities & Engineering group. You will design, build, commission, and qualify new equipment for drug substance production and develop domain expertise to support operations at start-up.

Responsibilities include commissioning and qualification of manufacturing systems per GMP, lifecycle support for CIP/SIP/autoclave systems, and collaboration with regulatory inspectors to ensure compliance and continuous