Computer Systems Validation Engineer

📋 Description

• Plan, execute, document, and maintain computer system validation activities in accordance with GAMP
• Develop and maintain comprehensive validation documentation, including Validation Plans, User
• Conduct system risk assessments to establish appropriate validation scope, testing requirements
• Ensure computerized systems remain in a validated state through periodic reviews, change control
• Assess software releases, system modifications, and other changes for potential validation impact
• Develop and maintain SOPs, work instructions, validation templates, and other controlled

🎯 Requirements

• 4+ years of direct Computer System Validation (CSV) experience within a regulated life sciences
• Hands-on experience validating life sciences or clinical applications such as QMS, CTMS, LIMS
• Strong working knowledge of GAMP 5, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU
• High school diploma or GED required; a degree in Computer Science, Engineering, Life Sciences, or a
• Strong understanding of risk-based validation principles, documentation practices, testing
• Highly organized with strong attention to detail and the ability to manage multiple priorities

🎁 Benefits

• Annual salary range of $80,000–$120,000 USD for full-time team members.
• 100% remote position within the United States.
• Less than 5% travel, with occasional planned travel as required.
• Paid Time Off (PTO) and company-paid holidays.
• Employer-paid medical, dental, and vision insurance plan options.
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA).