Senior CSV Analyst – GxP Validation & CSA Expert

Katalyst CRO

San Francisco (CA)

On-site

USD 120,000 - 150,000

Full time

2 days ago

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Job summary

Katalyst CRO in San Francisco, CA seeks a Senior Computer System Validation (CSV) Analyst to lead validation and compliance for GxP computerized systems in a regulated life sciences environment. You will apply GAMP 5, 21 CFR Part 11, EU Annex 11, CSA principles, and risk-based validation to ensure systems remain validated throughout their lifecycle.

Responsibilities include developing Validation Plans, URS, FS, IQ/OQ/PQ, UAT, and traceability matrices; ensuring systems stay validated; supporting

Qualifications

Bachelor's degree in a relevant field.
58+ years of experience in Computer System Validation, Quality Systems, or GxP IT environments.
Hands-on experience validating GxP computerized systems in pharmaceutical/biotechnology/regulated industries.
Experience with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA.

Responsibilities

Lead and execute CSV activities throughout the system lifecycle.
Develop and maintain Validation Plans, URS, FS, Risk Assessments, test protocols, and validation reports.
Execute and document IQ/OQ/PQ, UAT, regression, and risk-based testing as applicable.
Ensure computerized systems remain in a validated state throughout their lifecycle.
Perform GxP impact assessments, validation risk assessments, and system categorization.
Apply GAMP 5 and CSA principles to validation strategies and testing approaches.
Support 21 CFR Part 11 and EU Annex 11 compliance assessments.
Review system requirements, specifications, test scripts, and traceability matrices.
Support Change Control, Deviation, CAPA, and Periodic Review activities.
Review and assess audit trails, user access, electronic records, and electronic signatures.
Support internal audits and FDA/regulatory inspection readiness.
Collaborate with IT, Quality Assurance, Business Process Owners, System Owners, and vendors.
Identify validation gaps and develop appropriate remediation strategies.
Ensure validation documentation is accurate, complete, traceable, and inspection-ready.
Support system upgrades, implementations, migrations, and integrations.
Provide technical guidance and mentoring to junior CSV team members.