Lab Systems Validation Associate Scientist

Amgen; Thousand Oaks (CA); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Retirement and Savings Plan

Group medical/dental/vision

Job summary

Amgen in Thousand Oaks, CA seeks an Associate Scientist PKMD Lab Operations to ensure validation of laboratory systems and equipment across lifecycle.

You will lead computerized system validation, risk assessments, change control, and documentation, partnering with scientists, IT, QA, and vendors to uphold data integrity and regulatory compliance. A strong writing and cross-functional collaboration skillset is essential for success.

Qualifications

• Masters degree (or higher) with 1 year laboratory experience or a Bachelors with 3 years in a lab.
• Experience with computerized system validation and lifecycle management.
• Knowledge of GLP/GCP or other regulated environments.
• Strong writing, organizational, and stakeholder communication skills.

Responsibilities

• Lead and support validation activities for computerized systems and lab software.
• Develop risk-based validation strategies and maintain validation deliverables.
• Coordinate qualification and validation testing and ensure a validated state throughout lifecycle.
• Ensure compliance with GxP, data integrity, and regulatory requirements.
• Collaborate cross-functionally with scientists, IT, QA, and vendors.

Skills

Technical writing

Documentation

Communication

Project coordination

Cross-functional collaboration

Education

Masters degree in a related field

Bachelors degree in a related field

Job description

Amgen in Thousand Oaks, CA seeks an Associate Scientist PKMD Lab Operations to ensure validation of laboratory systems and equipment across lifecycle.

You will lead computerized system validation, risk assessments, change control, and documentation, partnering with scientists, IT, QA, and vendors to uphold data integrity and regulatory compliance. A strong writing and cross-functional collaboration skillset is essential for success.