Associate Scientist - PKMD - Lab Operations
Amgen · Thousand Oaks, CA
ResearchFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Amgen seeks an Associate Scientist to lead computerized system validation and lifecycle management for laboratory equipment and GxP-regulated systems. The role ensures compliance with FDA regulations, data integrity, and inspection readiness through validation planning, change control, and cross-functional collaboration.
What they're looking for
- Master's degree with 1+ year laboratory experience, or Bachelor's degree with 3+ years laboratory experience
- Experience with computerized system validation and lifecycle management
- Knowledge of GLP, GCP, or other regulated environments
- Understanding of data integrity principles and 21 CFR Part 11 requirements
- Strong technical writing and documentation skills
- Project coordination and cross-functional communication abilities
What you'll be doing
- Lead validation activities for computerized systems, software, and GxP-regulated applications using risk-based approaches
- Author and maintain validation documentation including plans, risk assessments, protocols, and summary reports
- Evaluate and support system changes, upgrades, implementations, and decommissioning activities
- Review system security, user access controls, audit trails, and data integrity mechanisms for compliance
- Partner with laboratory operations, IT, quality, and vendors to coordinate validation testing and issue resolution
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.