Specialist Manufacturing – Cleaning Validation

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

Role

Specialist Manufacturing – Cleaning Validation within Amgen’s Drug Substance Supply supporting multi-product biologics manufacturing.

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 a SME during regulatory inspections.

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.

Preferred

Experience in biologics manufacturing, equipment validation, regulatory submissions, and GxP standards (e.g., FDA 21 CFR Parts 210/211, EudraLex Annex 15).

High-value

Biologics (likely recombinant or cell therapy), validation for sterile equipment and cleaning processes, supporting both clinical and commercial phases, cross-functional collaboration across Quality, Engineering, Manufacturing, and Supply Chain.

Work setup

On-site with flexible hours, including weekends and holidays, to align with manufacturing schedules.