Senior CIP/SIP Autoclave Process Engineer

Amgen Inc.; Holly Springs (NC); Vor Ort; USD 115.000 - 156.000; Vollzeit

Zusammenfassung

Amgen Inc. in Holly Springs, NC seeks a Senior Process Engineer specializing in CIP, SIP, and autoclave systems to partner with Facilities & Engineering for design, build, and qualification of drug substance equipment.

You will own system ownership and provide lifecycle support across commissioning, qualification, startup readiness, and manufacturing operations. The role emphasizes regulatory compliance, collaboration with Manufacturing, Quality, and Process Development, and proactive

Qualifikationen

• Doctorate degree OR Master’s degree with 2 years of Engineering experience
• Bachelor’s degree with 4 years of Engineering experience OR
• Associate’s degree and 8 years of Engineering experience OR
• High school diploma / GED and 10 years of Engineering experience

Aufgaben

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Lead CIP, SIP and autoclave engineering and related equipment.
• Support commissioning, qualification, startup readiness, manufacturing operations.
• Develop maintenance programs and ensure regulatory compliance.
• Collaborate with Manufacturing, Quality, Process Development and maintenance teams.
• On-site travel up to 10% domestically/internationally.

Kenntnisse

Leadership

Communication

Project management

Biopharmaceutical operations

Regulatory compliance

Ausbildung

Doctorate degree

Master’s degree with 2 years of engineering experience

Bachelor’s degree with 4 years engineering experience

Associate’s degree with 8 years engineering experience

High school diploma / GED with 10 years engineering experience

Jobbeschreibung

Amgen Inc. in Holly Springs, NC seeks a Senior Process Engineer specializing in CIP, SIP, and autoclave systems to partner with Facilities & Engineering for design, build, and qualification of drug substance equipment.

You will own system ownership and provide lifecycle support across commissioning, qualification, startup readiness, and manufacturing operations. The role emphasizes regulatory compliance, collaboration with Manufacturing, Quality, and Process Development, and proactive