Computer Systems Validation Engineer

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Computer Systems Validation Engineer based in United States.** This role is responsible for ensuring that computerized systems supporting clinical research and business operations remain validated, compliant, secure, and fit for their intended use. You’ll manage validation activities across both GxP-regulated systems and non-GxP systems that handle PHI and sensitive clinical data. The position offers the opportunity to work at the intersection of technology, quality, regulatory compliance, and clinical operations. You’ll collaborate closely with Quality Assurance, Information Technology, Clinical Operations, and business stakeholders throughout the system lifecycle. Your work will directly support data integrity, regulatory readiness, and the reliability of systems used in a highly regulated environment. This is an ideal opportunity for an experienced CSV professional who is organized, detail-oriented, and comfortable managing multiple priorities in a fast-paced setting. ### Accountabilities: - Plan, execute, document, and maintain computer system validation activities in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable GxP requirements. - Develop and maintain comprehensive validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Test Cases, Traceability Matrices, and Validation Summary Reports. - Conduct system risk assessments to establish appropriate validation scope, testing requirements, and controls. - Ensure computerized systems remain in a validated state through periodic reviews, change control, upgrades, patches, configuration changes, and ongoing lifecycle management. - Assess software releases, system modifications, and other changes for potential validation impact and coordinate appropriate activities. - Develop and maintain SOPs, work instructions, validation templates, and other controlled documentation supporting computerized system compliance. - Partner with Quality Assurance, IT, Clinical Operations, and business stakeholders to address validation requirements, data integrity, security, and regulatory compliance. - Participate in regulatory inspections, customer audits, and internal quality audits, providing validation documentation and supporting inspection readiness. ### Requirements: - 4+ years of direct Computer System Validation (CSV) experience within a regulated life sciences, clinical research, or similarly controlled environment. - Hands-on experience validating life sciences or clinical applications such as QMS, CTMS, LIMS, eSource, or eBinder platforms. - Strong working knowledge of GAMP 5, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU Clinical Trials Regulation 536/2014, data integrity principles, and software development lifecycles. - High school diploma or GED required; a degree in Computer Science, Engineering, Life Sciences, or a related field is preferred, or equivalent professional experience. - Strong understanding of risk-based validation principles, documentation practices, testing, traceability, and computerized system lifecycle management. - Highly organized with strong attention to detail and the ability to manage multiple priorities, deadlines, and validation activities in a fast-paced environment. - Strong analytical and problem-solving skills, with the ability to collaborate effectively with technical, quality, clinical, and business stakeholders. - Comfortable working independently while maintaining clear communication and strong cross-functional relationships. ### 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). - Bi-weekly employer HSA contributions. - Company-paid Short-Term Disability and Long-Term Disability coverage. - 401(k) retirement plan with company match. - Inclusive workplace culture focused on diversity, belonging, and equal opportunity. - Reasonable accommodations available throughout the application and employment process for qualified individuals who need support.