Computer Systems Validation Engineer

Role overview

A Computer Systems Validation Engineer is needed to safeguard the integrity, security, and regulatory compliance of computerized systems used across a clinical research and health services organization. The role spans both GxP-regulated platforms and non-GxP systems that handle protected health information and sensitive clinical data, partnering with Quality Assurance, IT, Clinical Operations, and business stakeholders throughout each system's lifecycle.

• Plan, execute, and maintain validation activities for computerized systems in line with GAMP 5, FDA
  21CF
  RPart
  11, EUAnnex
  11, and applicable GxP regulations.
• Develop and maintain validation documentation, including Validation Plans, User Requirements Specifications, Functional Specifications, Risk Assessments, Test Cases, Traceability Matrices, and Validation Summary Reports.
• Conduct system risk assessments to determine validation scope and testing depth, and keep systems in a validated state through periodic reviews, change control, and lifecycle management.
• Evaluate software releases, upgrades, patches, and configuration changes for validation impact.
• Author standard operating procedures, work instructions, and validation templates.
• Support regulatory inspections, customer audits, and internal quality audits.

• 4+ years of direct computer systems validation experience in a regulated life sciences or clinical research environment.
• Hands-on experience validating clinical or life sciences applications such as QMS, CTMS, LIMS, eSource, or eBinder.
• Strong working knowledge of GAMP5, FDA
  21CF
  RPart
  11, ICHE6(R3) Good Clinical Practice, EUCTR
  536/2014, data integrity principles, and software development life cycles.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced setting.
• High school diploma or GED required; a degree in Computer Science, Engineering, Life Sciences, or a related field is preferred.

• Experience supporting GxP audits or regulatory inspections directly.
• Familiarity with clinical research operations and community-based health programs.

• Fully remote within the United States; less than 5% travel expected.
• Expected pay range of $80,000 to $120,000 USD per year for full-time team members.
• Paid time off and company-paid holidays.
• 100% employer-paid medical, dental, and vision insurance plan options.
• Health Savings Account and Flexible Spending Accounts, with a bi-weekly HSA employer contribution.
• Company-paid short-term and long-term disability coverage.
• 401(k) retirement plan with company match.
• Visa sponsorship is not available for this role.