Senior CSV Analyst

Katalyst CRO; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

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.

Skills

GAMP 5

21 CFR Part 11

EU Annex 11

CSA principles

risk-based validation

CSV execution

regulatory compliance

technical writing

communication skills

Education

Bachelor's degree in Computer Science/IT/Engineering/Life Sciences/Pharmacy

Tools

Veeva

SAP

LIMS

MES

QMS

ERP

Job description

Job Description

We are seeking an experienced Senior Computer System Validation (CSV) Analyst to support validation and compliance activities for GxP computerized systems in a regulated pharmaceutical/biotechnology environment. The ideal candidate will have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, and Computer Software Assurance (CSA) principles.

Job Description

We are seeking an experienced Senior Computer System Validation (CSV) Analyst to support validation and compliance activities for GxP computerized systems in a regulated pharmaceutical/biotechnology environment. The ideal candidate will have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, and Computer Software Assurance (CSA) principles.

Responsibilities

• Lead and execute Computer System Validation (CSV) activities throughout the system lifecycle.
• Develop and maintain Validation Plans, User Requirements Specifications (URS), Functional Specifications (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.

Requirements

• Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, or a related field.
• 58+ years of experience in Computer System Validation, Quality Systems, or GxP IT environments.
• Strong experience validating GxP computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries.
• Hands-on experience with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA.
• Experience with enterprise GxP applications such as Veeva, SAP, LIMS, MES, QMS, ERP, or clinical systems is preferred.
• Strong technical writing, analytical, problem-solving, and communication skills.
• Ability to manage multiple validation projects and priorities in a regulated environment.