Drug Product Manufacturing Process Owner Deviations & CAPA

Amgen; Thousand Oaks (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive benefits package

Discretionary annual bonus

Stock-based incentives

Flexible work options

Job summary

Amgen in Thousand Oaks is seeking a Specialist Manufacturing – Production Process Owner in DP Operations to ensure our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. You will play a key role in Major Deviations from a DP Process Standpoint.

Collaborating across Capital, Engineering, Process Development, Quality and other functions, you will define requirements, develop SOPs, batch records, training, validation, and automation configurations

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 timely investigation and resolution of manufacturing deviations.
• Participate in root cause analyses (RCA) and human performance evaluations.
• Contribute to the development and implementation of CAPAs and monitor CAPA effectiveness.
• Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs).
• Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
• Maintain documentation to reflect operational practices and regulatory requirements.
• Support implementation of new processes, equipment, and major initiatives within Drug Product operations.
• Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
• Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations.
• Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement.
• Develop and implement data-driven solutions to improve yield, reliability, and compliance.
• Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements.
• Assist in developing and executing process validation protocols and reports.
• Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
• Support establishment of process parameters, control limits, and performance reporting.
• Support change control activities to ensure GMP, regulatory, and operational compliance.
• Evaluate and justify process or equipment changes and assist with project execution.
• Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations.

Skills

Deviations management

CAPA

Process validation

GMP compliance

Data analytics

Spotfire

JMP

Excel

Cross-functional collaboration

Education

Doctorate degree

Master’s degree with manufacturing experience

Bachelor’s degree with manufacturing experience

Associate’s degree with manufacturing experience

High school diploma or GED with manufacturing experience

Tools

Spotfire

JMP

Excel

Job description

Amgen in Thousand Oaks is seeking a Specialist Manufacturing – Production Process Owner in DP Operations to ensure our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. You will play a key role in Major Deviations from a DP Process Standpoint.

Collaborating across Capital, Engineering, Process Development, Quality and other functions, you will define requirements, develop SOPs, batch records, training, validation, and automation configurations