Senior CSV Analyst - Remote, Impactful Validation

Remote Jobs; United States; Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual performance/merit reviews

Annual performance bonuses

Equity

Flexible time off

401K with company match

Health (medical, dental, vision) PPO &

Remote work environment

Job summary

CG Oncology, Inc. is seeking a Senior Analyst, Computer Systems Validation (CSV) to lead validation planning, execution, and lifecycle activities for GxP computerized systems used in regulated operations.

You will collaborate with IT, QA, system owners, business partners, and vendors to deliver inspection-ready evidence. The role emphasizes risk-based validation, test planning, and maintaining compliant, validated systems while supporting changes, migrations, and retirements.

Qualifications

• Five or more years of progressive experience in computer systems validation, quality systems, IT quality, or regulated systems within biotechnology, pharmaceutical, medical device, or other life sciences.
• At least three years of direct experience authoring and executing CSV lifecycle deliverables for GxP computerized systems.
• Experience validating SaaS/cloud, configured, and/or custom applications using a risk-based approach.
• Working knowledge of 21 CFR Part 11, GxP data integrity expectations, GAMP 5, SDLC, change control, and good documentation practices.
• Demonstrated ability to work with business owners, QA, IT, vendors, and project teams to deliver compliant systems on schedule.

Responsibilities

• Plan and execute validation activities for new and existing computerized systems.
• Develop risk-based validation strategies, plans, schedules, and deliverable matrices.
• Author, review, and maintain validation deliverables and test evidence.
• Coordinate qualification and UAT testing with clear, attributable documentation.
• Maintain validated state through periodic reviews and revalidation activities.
• Support supplier qualification and risk assessment with vendor documentation and testing.

Skills

CSV expertise

GxP compliance

SaaS validation

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in IT/CS/Engineering

Tools

GAMP 5

Quality systems

Job description

CG Oncology, Inc. is seeking a Senior Analyst, Computer Systems Validation (CSV) to lead validation planning, execution, and lifecycle activities for GxP computerized systems used in regulated operations.

You will collaborate with IT, QA, system owners, business partners, and vendors to deliver inspection-ready evidence. The role emphasizes risk-based validation, test planning, and maintaining compliant, validated systems while supporting changes, migrations, and retirements.