Base Career helps you apply smarter for this job.
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.
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.
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
Terryville, USA
, USA
, USA
, USA
Tampa, USA
Houston, USA
, USA
Quincy, USA
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.
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: 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.
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
#LI-Remote
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
Clinical research organization expanding patient access to clinical trials for new treatments and cures across the United States.
Visit company websiteJobs and hiring trendsUSD 80000-120000 / year
Mid · 4+ years experience
Remote
Apply faster on company sites with our extension.