Senior CSV Analyst

Creative Solutions Services, LLC; San Francisco (CA); On-site; USD 120,000 - 160,000; Full time

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.

Skills

CSV/Quality Systems

GxP IT environments

Technical writing

Regulatory compliance

Project management

Education

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

Tools

Veeva

SAP

LIMS

MES

QMS

ERP

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.
• 5-8+ 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.