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.
To learn more about Care Access, visit www.CareAccess.com.
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
How We Work Together
- 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.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected pay range for this role is $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
Mandatory Employer Disclosures
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
