Biologics Cleaning Validation Specialist – On-Site GMP

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

Job summary

Amgen in Thousand Oaks seeks a Specialist Manufacturing – Cleaning Validation for the Drug Substance Supply, supporting multi-product biologics manufacturing. You will own validation requirements, lead cross-functional projects from planning to execution, and provide technical support during manufacturing and troubleshooting.

Responsibilities include developing validation strategies and documentation, supporting commissioning and audits, monitoring validation status, and serving as a SME during

Qualifications

• Doctorate or Master's with 2+ years, Bachelor's with 4+ years, or equivalent GMP validation/engineering experience.
• Strong technical, data analysis, and communication skills.

Responsibilities

• Own validation requirements for NPIs and existing products.
• Lead cross-functional projects from planning to execution.
• Provide technical support during manufacturing and troubleshooting.
• Develop validation strategies and documentation.
• Support commissioning and audits.
• Monitor validation status and serve as SME during regulatory inspections.

Skills

Technical skills

Data analysis

Communication skills

Education

Doctorate or Master’s with 2+ years

Bachelor’s with 4+ years

Job description

Amgen in Thousand Oaks seeks a Specialist Manufacturing – Cleaning Validation for the Drug Substance Supply, supporting multi-product biologics manufacturing. You will own validation requirements, lead cross-functional projects from planning to execution, and provide technical support during manufacturing and troubleshooting.

Responsibilities include developing validation strategies and documentation, supporting commissioning and audits, monitoring validation status, and serving as a SME during