Cleaning Validation Specialist Cross-Functional Project Lead

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

Job summary

Amgen Thousand Oaks is seeking a Specialist Manufacturing - Cleaning Validation to lead equipment cleanability work, MAC/MAR calculations, and validation strategies across NPIs and existing products. You will coordinate cross-functional teams across Manufacturing, Quality, Engineering, and Process Development to ensure compliant, validated operations on site.

The role requires deep expertise in cleaning validation, regulatory knowledge (FDA/ICH), and strong data analysis, technical writing, and

Qualifications

• Doctorate degree OR Master’s with validation/engineering/GMP/process development experience.
• Bachelor’s degree with 4+ years in Validation, Engineering, GMP Manufacturing, or Process Development.
• Associate’s degree 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 equipment cleanability assessments and validation requirements for NPIs and existing products, including MAC/MAR.
• Lead cross-functional projects from scope to implementation with multiple departments.
• Provide technical support on-floor, testing, validation execution, deviation investigations, and CAPAs.
• Develop and approve cleaning characterization/validation strategies, plans, and sampling.
• Assess impacts for new products, equipment, processes; support commissioning.
• Lead validation quality records, changes controls, deviations, and effectiveness checks.
• Maintain site validation plans and monitor trends; prepare regulatory audit support.
• Represent Cleaning Validation during regulatory audits; coach colleagues.
• Mentor and train colleagues in area of expertise.
• Ability to work on-site with flexible schedules.
• Available to work various shifts including weekends/holidays.

Skills

Cross-functional leadership

Technical writing

Data analysis

Regulatory knowledge

GMP manufacturing knowledge

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 work, MAC/MAR calculations, and validation strategies across NPIs and existing products. You will coordinate cross-functional teams across Manufacturing, Quality, Engineering, and Process Development to ensure compliant, validated operations on site.

The role requires deep expertise in cleaning validation, regulatory knowledge (FDA/ICH), and strong data analysis, technical writing, and