Computer System Validation (CSV)

Computer System Validation (CSV) – Job Description

Job Details

• Location: Wilmington, Delaware (DE)

• Duration: 6 months

• GBaMS ReqID: 11036449

• Overall Experience: 8+ years

• Relevant Experience: Minimum 5 years in Computer System Validation (CSV) for GxP systems

Educational Qualifications

• Bachelor of Science (BSc)

• Bachelor of Technology (BTech)

• Bachelor's degree in Pharmacy

Must-Have Technical/Functional Skills – Core CSV

• Strong experience in Computer System Validation (CSV) for GxP-regulated systems.

• Knowledge of 21 CFR Part 11 and 21 CFR Part 820.

• Understanding of GxP regulatory requirements.

• Knowledge of GAMP 5 guidelines.

• Familiarity with Sarbanes-Oxley (SOX) compliance.

• Knowledge of EU Annex 11 and other applicable regulatory requirements.

• Understanding of ISO 9001 standards.

• Familiarity with ITIL processes and practices.

• Experience with audit and inspection readiness.

• Experience conducting periodic reviews of validated systems.

• Experience performing access roster reviews and audit trail reviews.

• Knowledge of deviation and Corrective and Preventive Action (CAPA) management.

• Experience with SOP and policy compliance processes.

• Understanding of risk-based testing aligned with Computer Software Assurance (CSA) fundamentals.

• High-level understanding of Veeva Vault application suites.

CSV Documentation and Deliverables

• Author and maintain User Requirements Specifications (URS).

• Prepare and review Functional Specifications (FS).

• Develop and execute validation protocols.

• Prepare final validation reports.

• Develop and maintain validation plans and reports.

• Ensure validation documentation complies with applicable GxP and regulatory requirements.

• Maintain accurate, complete, and traceable validation records.

R&D Domain Knowledge

• High-level understanding of Biostatistics.

• Knowledge of Clinical operations and processes.

• Familiarity with Discovery and research activities.

• Understanding of Medical Affairs.

• Knowledge of Pharmacovigilance.

• Familiarity with Regulatory Affairs.

• High-level understanding of Robotic Process Automation (RPA) bots in GxP environments.

• Familiarity with R&D Artificial Intelligence (AI) applications in GxP-regulated environments.

Essential Skills

• Computer System Validation (CSV)

• GxP Compliance

• 21 CFR Part 11

• 21 CFR Part 820

• GAMP 5

• Computer Software Assurance (CSA)

• Risk-Based Testing

• URS and Functional Specifications

• Validation Protocols

• Validation Plans and Reports

• Audit and Inspection Readiness

• Periodic Reviews

• Access Roster Reviews

• Audit Trail Reviews

• Deviation and CAPA Management

• SOP and Policy Compliance

• Veeva Vault

Desirable Skills

• SOX Compliance

• EU Annex 11

• ISO 9001

• ITIL

• Biostatistics

• Clinical Operations

• Discovery Research

• Medical Affairs

• Pharmacovigilance

• Regulatory Affairs

• RPA GxP Bots

• R&D AI GxP Applications

Key Responsibilities

• Support computer system validation activities for GxP-regulated systems.

• Develop, review, and maintain validation documentation.

• Ensure compliance with applicable regulatory standards and internal policies.

• Perform periodic reviews, access roster reviews, and audit trail reviews.

• Support audit and inspection readiness activities.

• Manage deviations and CAPAs related to validated systems.

• Apply risk-based testing approaches aligned with CSA principles.

• Support validation activities for R&D systems and applications.

• Collaborate with Quality, IT, Clinical, and Regulatory Affairs teams.

• Maintain documentation and evidence demonstrating the validated state of systems.