Remote CSV Engineer - Life Sciences & GxP Compliance

Care Access; Boston (MA); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

PTO and Holidays

Health insurance options

HSA & FSA programs

HSA employer contribution

Disability insurance

401(k) with company match

Job summary

Care Access is seeking a Computer System Validation (CSV) Engineer to validate, maintain, and ensure regulatory compliance for computerized systems across the organization. The role supports both GxP and non-GxP systems handling PHI and clinical data.

The ideal candidate will plan and execute validation activities, develop documentation, and collaborate with QA, IT, Clinical Operations, and stakeholders to keep systems validated throughout their lifecycle. Remote work within the US is supported.

Qualifications

• Minimum high school diploma or GED required.
• Prefer a degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional 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)

Responsibilities

• Plan, execute, and maintain validation activities for computerized systems per GAMP 5 and GxP regulations.
• Develop and maintain validation docs: plans, URS, FS, risk assessments, test cases, traces, and summaries.
• 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 SOPs, work instructions, and validation templates.
• Participate in regulatory inspections, customer audits, and internal quality audits.

Skills

GAMP 5 guidelines

FDA 21 CFR Part 11

ICH E6(R3) Good Clinical Practice

data integrity rules

SDLC

Education

High school diploma or GED

Degree in Computer Science, Engineering, Life Sciences, or related field

Tools

QMS

CTMS

LIMS

eSource

eBinder

Job description

Care Access is seeking a Computer System Validation (CSV) Engineer to validate, maintain, and ensure regulatory compliance for computerized systems across the organization. The role supports both GxP and non-GxP systems handling PHI and clinical data.

The ideal candidate will plan and execute validation activities, develop documentation, and collaborate with QA, IT, Clinical Operations, and stakeholders to keep systems validated throughout their lifecycle. Remote work within the US is supported.