Associate Scientist - PKMD - Lab Operations
Amgen
September 19, 2026
Full-time
Remote friendly (Thousand Oaks, CA)
Worldwide
Operations
Role: Associate Scientist in PKMD Lab Operations focusing on ensuring GxP-regulated laboratory equipment and computerized systems remain compliant and inspection-ready throughout their lifecycle. Responsibilities: lead validation activities for laboratory systems, develop risk-based validation strategies, author and review validation documentation, manage change control, support system implementation and upgrades, ensure data integrity, and collaborate with cross-functional teams including IT, Quality, and vendors. Requirements: Masterโs degree with 1+ year or Bachelorโs with 3+ years of lab experience; experience in validated GxP environments, computerized system validation, and lifecycle management. Preferred: 5+ years supporting laboratory operations, familiarity with GLP/GCP, and knowledge of validation methodologies and data integrity principles. HighValue: focus on regulated laboratory systems supporting biopharma R&D, quality assurance, or manufacturing; experience with automation platforms, validation documentation, and audit readiness. WorkSetup: details not specified; likely hybrid or on-site based on lab environment.