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.

Responsibilities

- Plan, execute, and maintain validation activities for computerized systems in line with GAMP 5, FDA 21 CFR Part 11, EU Annex 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.

Requirements

- 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 GAMP 5, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU CTR 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.

Nice to have

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

Benefits and work setup

- 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.