Associate Scientist - CSV & Lab Systems Lead

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is seeking an Associate Scientist PKMD Lab Operations to lead validation activities for computerized systems and maintain data integrity across life-cycle stages.

You will collaborate with system owners, laboratory scientists, IT, quality, and vendors to ensure regulatory readiness and compliant data generation while supporting equipment setup and SOP adherence.

Qualifications

• Masters degree and 1 year of laboratory experience
• OR
• Bachelor's degree and 3 years of laboratory experience
• Experience with computerized system validation and lifecycle management? (from text)

Responsibilities

• Lead validation activities for CSV and GxP systems.
• Develop validation strategies using risk-based validation principles.
• Maintain validation deliverables including plans, risk assessments, specifications, protocols, traces, and reports.
• Coordinate qualification and validation testing activities.
• Ensure systems remain validated throughout their lifecycle.
• Support compliance, data integrity, and regulatory inspections.

Skills

Validation

GxP

Data Integrity

Lab Operations

Cross-Functional

Documentation

Regulated Environments

Education

Master's degree

Bachelor's degree

Job description

Amgen in Thousand Oaks, CA is seeking an Associate Scientist PKMD Lab Operations to lead validation activities for computerized systems and maintain data integrity across life-cycle stages.

You will collaborate with system owners, laboratory scientists, IT, quality, and vendors to ensure regulatory readiness and compliant data generation while supporting equipment setup and SOP adherence.