Cleaning Validation Specialist – Manufacturing Excellence

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Stock-based incentives

Flexible work models

Retirement and savings plan

Job summary

Amgen Thousand Oaks is seeking a Specialist Manufacturing – Cleaning Validation to lead equipment cleanability assessments and validation activities for NPIs and existing products. You will collaborate across Manufacturing, Quality, Engineering, Process Development, and Supply Chain to ensure compliant, robust cleaning strategies.

The role requires advanced degrees with 2+ years of validation/GMP experience, strong technical writing, and the ability to work on‑site with flexible scheduling to

Qualifications

• Doctorate or Master’s with validation, GMP manufacturing, or process development experience.
• Bachelor’s with 4+ years in validation, engineering, GMP manufacturing, or process development.
• Associate’s with 8+ years in validation, engineering, GMP manufacturing, or process development.
• High school diploma with 10+ years in validation, engineering, GMP manufacturing, or process development.

Responsibilities

• Own cleaning validation requirements for NPIs and existing products, including MAC/MAR assessments.
• Lead cross-functional projects across Manufacturing, Quality, Engineering, Process Development and Supply Chain.
• Provide on‑floor troubleshooting, function testing, validation execution, deviation investigations and CAPA support.
• Develop and approve cleaning characterization and validation strategies, protocols, reports and sampling plans.
• Represent Cleaning Validation during regulatory audits and inspections and support site improvements.

Skills

Validation

GMP manufacturing

Process development

Cross-functional leadership

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

Microsoft Excel

Job description

Amgen Thousand Oaks is seeking a Specialist Manufacturing – Cleaning Validation to lead equipment cleanability assessments and validation activities for NPIs and existing products. You will collaborate across Manufacturing, Quality, Engineering, Process Development, and Supply Chain to ensure compliant, robust cleaning strategies.

The role requires advanced degrees with 2+ years of validation/GMP experience, strong technical writing, and the ability to work on‑site with flexible scheduling to