Senior Process Engineer – CIP/SIP & Autoclaves

Amgen; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen's Facilities & Engineering team seeks a Senior Process Engineer focused on CIP, SIP and Autoclave systems to design, commission, and qualify new drug substance equipment. You will partner with the corporate engineering team to ensure 24/7 plant reliability, lead commissioning, validation runs, and ongoing improvements for GMP-compliant operations.

The role requires advanced engineering degrees and 6+ years in biopharma operations, strong leadership, and travel up to 10% domestically.

Qualifications

• PhD or MS/BS in Engineering with biopharmaceutical experience.
• 6+ years in Biopharmaceutical operations/manufacturing preferred.
• Experience with GMP equipment, CIP/SIP/autoclaves, and QC readiness.

Responsibilities

• Design, build, commission and qualify CIP/SIP/autoclave systems for drug substance production.
• Provide lifecycle support and technical ownership for related equipment and automation.
• Lead commissioning, qualification runs, and troubleshooting to ensure GMP compliance.
• Develop maintenance programs, reviews, and upgrades to improve reliability.
• Collaborate with Manufacturing, Quality, Process Development and Maintenance teams.

Skills

CIP

SIP

Autoclave

Process Equipment

Commissioning

Qualification

Automation

Leadership

Cross-functional Collaboration

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Associate’s degree and 8 years experience

High school diploma / GED and 10 years experience

Job description

Amgen's Facilities & Engineering team seeks a Senior Process Engineer focused on CIP, SIP and Autoclave systems to design, commission, and qualify new drug substance equipment. You will partner with the corporate engineering team to ensure 24/7 plant reliability, lead commissioning, validation runs, and ongoing improvements for GMP-compliant operations.

The role requires advanced engineering degrees and 6+ years in biopharma operations, strong leadership, and travel up to 10% domestically.