Senior Associate Manufacturing – CAPA/EV

Amgen is hiring a Senior Associate Manufacturing – CAPA/EV in Thousand Oaks, Ventura County, California. This is a full-time, on-site position where you'll support critical manufacturing and quality operations for one of the world's leading independent biotechnology companies.

About the Role

As a Senior Associate in Manufacturing, you'll take on a pivotal role in our corrective and preventive action (CAPA) and environmental validation (EV) programs. You'll work hands-on with our production teams to maintain the highest standards of compliance, quality, and operational excellence that our patients depend on. Your work directly supports Amgen's mission to serve patients fighting serious illnesses, and you'll be part of a legacy of biotech innovation that spans four decades.

What You'll Do

• Lead and coordinate corrective and preventive action (CAPA) initiatives to address quality findings and prevent recurrence
• Support environmental validation studies and monitoring programs across manufacturing facilities
• Document, investigate, and resolve manufacturing deviations with attention to regulatory compliance
• Collaborate with quality assurance, engineering, and operations teams to implement solutions and drive continuous improvement
• Maintain detailed records and prepare reports for internal and regulatory review
• Support training and knowledge sharing to strengthen manufacturing team capability

What We're Looking For

• Bachelor's degree in chemistry, chemical engineering, life sciences, or a related field
• 2–5+ years of manufacturing or quality experience in pharmaceutical, biotech, or regulated environments
• Solid understanding of CAPA processes, GMP (good manufacturing practice), and FDA regulations
• Ability to manage multiple projects and communicate findings clearly to cross-functional teams
• Attention to detail, analytical mindset, and commitment to data integrity
• Experience with CAPA or validation documentation and systems is a plus

About Amgen

Since 1980, Amgen has been a pioneer at the intersection of biology and chemistry, developing medicines that address serious illnesses. We're driven by a single shared mission: to serve patients. Our manufacturing operations in Thousand Oaks and beyond are central to that promise.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.