Computer Systems Validation Engineer
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
How This Role Makes a Difference
The Computer System Validation Engineer is responsible for ensuring that computerized systems used across the organization are validated, maintained, and compliant with applicable regulatory requirements and internal policies. This role supports both GxP regulated systems and non-GxP systems that may store, process, or transmit PHI and sensitive clinical data. The CSV Engineer partners with Quality Assurance, Information Technology, Clinical Operations, and Business Stakeholders to ensure computerized systems remain fit for their intended use throughout their lifecycle while maintaining data integrity, security, and regulatory compliance.
How You'll Make An Impact
- Plan, execute, and maintain validation activities for computerized systems in accordance 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 (URS), Functional Specifications (FS), Risk Assessments, Test Cases, Traceability Matrices, Validation Summary Reports.
- Perform system risk assessments to determine validation scope and testing requirements.
- Ensure systems remain in a validated state through periodic reviews, change control, and lifecycle management.
- Review software releases, upgrades, patches, and configuration changes for validation impact.
- Develop standard operating procedures (SOPs), work instructions, and validation templates.
- Participate in regulatory inspections, customer audits, and internal quality audits.
The Expertise Required
- Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU CTR 536/2014, data integrity rules, and software development life cycles.
- Highly organized and able to manage multiple priorities in a fast paced environment.
Certifications/Licenses, Education, And Experience
- Minimum Education: Minimum high school diploma or GED required. Prefer a degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
- Minimum Experience: 4+ years of direct CSV experience in a regulated life sciences or clinical research field.
- Hands on experience with the validation of life sciences/clinical applications (e.g. QMS, CTMS, LIMS, eSource, eBinder).
Location & Travel
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 5% travel requirements. Occasional planned travel may be required as part of the role.
Pay & Benefits
- Expected pay range: $80,000 - $120,000 USD per year for full time team members.
- Benefits & Perks (US Full Time Employees):
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match