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.
- pply 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.
- bility to manage multiple validation projects and priorities in a regulated environment.
