CSV & Lab Systems Scientist (GxP)

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Stock options

Paid time off

Flexible work model

Job summary

Amgen in Thousand Oaks, CA is seeking an Associate Scientist – PKMD – Lab Operations to ensure validation of laboratory systems, equipment, and computerized tools across their lifecycle, keeping inspection-readiness and data integrity.

You will partner with lab scientists, IT, quality, and vendors to drive risk-based validation, change control, documentation, and training, while supporting audits and regulatory inspections.

Qualifications

• Master’s degree and 1 year of laboratory experience
• Bachelor’s degree and 3 years of laboratory experience
• Experience with computerized system validation and lifecycle management
• Experience in GLP, GCP, or other regulated environments
• Strong technical writing and documentation skills

Responsibilities

• Lead validation activities for computerized systems, laboratory software, and GxP-regulated apps
• Develop validation strategies using risk-based validation principles
• Write and maintain validation deliverables including plans, risk assessments, specifications, protocols, traceability matrices, and VSRs
• Coordinate qualification and validation testing activities
• Ensure systems stay in a validated state through their lifecycle
• Lead validation assessments for equipment and system changes
• Evaluate software upgrades, patches, and configuration changes
• Support audits and regulatory inspections
• Review security, access controls, audit trails, and data integrity controls
• Document validation exceptions, deviations, and corrective actions
• Collaborate with lab operations, SMEs, IT, quality, and vendors
• Provide validation guidance for new technologies and processes
• Support business continuity and disaster recovery planning

Skills

Technical writing

Communication

Project coordination

Cross-functional collaboration

Data integrity

Education

Master’s degree

Bachelor’s degree

Job description

Amgen in Thousand Oaks, CA is seeking an Associate Scientist – PKMD – Lab Operations to ensure validation of laboratory systems, equipment, and computerized tools across their lifecycle, keeping inspection-readiness and data integrity.

You will partner with lab scientists, IT, quality, and vendors to drive risk-based validation, change control, documentation, and training, while supporting audits and regulatory inspections.