Remote CSV Engineer Life Sciences Compliance

careaccess; United States; On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

PTO

Medical insurance

Dental insurance

Vision insurance

HSA

Employer HSA contribution

Short/Long Disability

401(k) match

Job summary

Care Access is seeking a Computer System Validation Engineer to validate, maintain, and ensure compliance of computerized systems across the organization, including GxP and non-GxP environments handling PHI and clinical data. You will partner with QA, IT, Clinical Operations, and business stakeholders to keep systems fit for intended use throughout their lifecycle.

The role emphasizes data integrity, security, and regulatory compliance, with a remote US-based work setup and travel under 5% as

Qualifications

• 4+ years of direct CSV experience in a regulated life sciences or clinical research field.
• Hands-on experience with validation of life sciences/clinical applications (e.g. QMS, CTMS, LIMS, eSource, eBinder).
• Minimum Education: high school diploma or GED; preferred degree in CS/Engineering/Life Sciences.

Responsibilities

• Plan, execute, and maintain validation activities for computerized systems per GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and GxP regulations.
• Develop and maintain validation documentation: Validation Plans, URS, FS, Risk Assessments, Test Cases, Traceability Matrices, Validation Summary Reports.
• Perform system risk assessments to determine validation scope and testing requirements.
• Ensure systems stay validated through periodic reviews, change control, and lifecycle management.
• Review software releases, upgrades, patches, and configuration changes for validation impact.
• Develop SOPs, work instructions, and validation templates.
• Participate in regulatory inspections, customer audits, and internal quality audits.

Skills

GAMP5

FDA 21 CFR Part 11

ICH E6(R3)

Data integrity

SDLC

Education

High school diploma or GED

Degree in Computer Science, Engineering or Life Sciences

Job description

Care Access is seeking a Computer System Validation Engineer to validate, maintain, and ensure compliance of computerized systems across the organization, including GxP and non-GxP environments handling PHI and clinical data. You will partner with QA, IT, Clinical Operations, and business stakeholders to keep systems fit for intended use throughout their lifecycle.

The role emphasizes data integrity, security, and regulatory compliance, with a remote US-based work setup and travel under 5% as