DP Manufacturing Process Owner – Deviations & CAPA

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Benefits package

Flexible work model

Job summary

Amgen is seeking a Specialist Manufacturing Production Process Owner at the Thousand Oaks site to ensure compliant, efficient, and continuously improving Drug Product operations. You will support Major Deviations, CAPAs, and documentation within GMP standards.

The role requires collaboration across Engineering, Quality, and Process Development, with data-driven problem solving and process optimization, contributing to safety and product quality.

Qualifications

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

Responsibilities

• Support deviation investigation and resolution.
• Participate in root cause analyses (RCA) and CAPA activities.
• Develop and maintain GMP-compliant documentation and records (CDOCs).
• Assist in process implementation, validation, and change control.
• Analyze data to identify trends and drive improvements in yield, reliability, and compliance.

Skills

Project coordination

Communication

Problem solving

Cross functional collaboration

Data analysis

Education

Doctorate degree

Master's degree + 2 years manufacturing experience

Bachelor's degree + 4 years manufacturing experience

Associate's degree + 8 years manufacturing experience

High school diploma/GED + 10 years manufacturing experience

Tools

CDOCs

Spotfire

JMP

Excel

Job description

Amgen is seeking a Specialist Manufacturing Production Process Owner at the Thousand Oaks site to ensure compliant, efficient, and continuously improving Drug Product operations. You will support Major Deviations, CAPAs, and documentation within GMP standards.

The role requires collaboration across Engineering, Quality, and Process Development, with data-driven problem solving and process optimization, contributing to safety and product quality.