Senior CSV Analyst: Validation Lead for GxP Systems

Creative Solutions Services, LLC

San Francisco (CA)

On-site

USD 120,000 - 160,000

Full time

9 days ago

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Job summary

Creative Solutions Services, LLC seeks a Senior CSV Analyst to support validation and compliance for GxP computerized systems in a regulated pharmaceutical/biotech environment. The role emphasizes risk-based validation, GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA-guided testing strategies.

You will lead validation efforts, develop validation plans, URS, FS, and traceability, review audit trails, and mentor junior staff while collaborating with IT, QA, and vendors to ensure inspection readiness.

Qualifications

Bachelor's degree in a relevant field (CS/IT/Engineering/Life Sciences/Pharmacy).
5–8+ years of experience in CSV, Quality Systems, or GxP IT environments.
Experience validating GxP computerized systems in regulated industries.
Hands-on experience with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA.
Experience with enterprise GxP applications (Veeva, SAP, LIMS, MES, QMS, ERP).
Strong technical writing, analytical, problem-solving, and communication skills.
Ability to manage multiple validation projects in a regulated environment.

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 IQ/OQ/PQ, UAT, regression, and risk-based testing as applicable.
Ensure computerized systems remain validated 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, QA, Business Process Owners, System Owners, and vendors.
Identify validation gaps and 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.