Associate Scientist - PKMD - Lab Operations

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As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

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Associate Scientist – PKMD – Lab Operations

Let’s do this. Let’s change the world. In this vital role you will be responsible for ensuring that laboratory equipment, computerized systems, and associated processes remain compliant, fit for intended use, and inspection-ready throughout their lifecycle. The role provides validation leadership and support for GxP-regulated systems and equipment, including planning, risk assessment, change control, testing, documentation, implementation, maintenance, and retirement activities.

This position partners with system owners, laboratory scientists, IT, automation, Quality, Data Integrity, and external vendors to maintain regulatory compliance and data integrity in alignment with 21 CFR Part 58 and Part 11 requirements. The Associate Scientist also supports equipment setup and assists scientific staff with compliant data generation, quality control, user access, reporting, and SOP adherence.

Key Responsibilities:

Computerized System Validation (CSV)

• Lead and support validation activities for computerized systems, laboratory software, and GxP-regulated applications.
• Develop validation strategies using risk-based validation principles.
• Author, review, and maintain validation deliverables including:
  • Validation Plans (VPR)
  • Risk Assessments
  • Requirements Specifications
  • Qualification Protocols
  • Traceability Matrices
  • Validation Summary Reports (VSR)

• Coordinate and execute qualification and validation testing activities.
• Ensure systems maintain a validated state throughout their lifecycle.

Change Control & Lifecycle Management

• Lead validation assessments for equipment and system changes.
• Evaluate software upgrades, patches, configuration changes, and system enhancements.
• Participate in system implementation, expansion, relocation, and decommissioning activities.
• Support periodic reviews and lifecycle documentation maintenance.

Compliance & Data Integrity

• Ensure compliance with applicable regulations, including GxP requirements and electronic records controls.
• Support audit readiness and regulatory inspections.
• Review system security, user access controls, audit trail functionality, and data integrity controls.
• Investigate and document validation exceptions, deviations, and corrective actions.

Cross-Functional Collaboration

• Partner with laboratory operations, system owners, SMEs, IT, automation, quality, and vendors.
• Facilitate validation kickoff meetings, testing coordination, and issue resolution.
• Provide validation guidance for new technologies, laboratory instruments, and business processes.
• Support business continuity and disaster recovery planning for regulated systems.

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