Senior Computer System Validation (CSV) Consultant

Dawar Consulting•San Diego, CA

3d•Onsite

About The Position

Our client, a world leader in biotechnology and life sciences, is looking for a Senior Computer System Validation (CSV) Consultant based out of San Diego, CA. This is a long-term contract position with the possibility of extension. The role provides Quality Assurance oversight for computerized systems used across laboratory, manufacturing, and quality operations, ensuring compliance with global regulatory standards. Reporting to the Site Quality Head, the consultant will lead validation activities throughout the system lifecycle and ensure systems remain inspection-ready.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
8+ years of experience in Computer System Validation within the life sciences or regulated industry.
Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity (ALCOA+).
Experience with GxP systems such as EDMS, LMS, LIMS, and MES.
Familiarity with Quality systems including Change Control, Deviations, CAPA, and Document Management.

Responsibilities

Lead and support the computer system validation lifecycle for GxP systems.
Author, review, and approve validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
Conduct system requalification and periodic reviews to maintain validated system status.
Ensure computerized systems comply with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Serve as the Quality Lead for validation projects, guiding teams through system implementation and validation activities.
Partner with cross-functional teams including IT, Engineering, Manufacturing, QC, and Quality to ensure compliant system design and deployment.
Provide guidance on data integrity, security controls, and risk-based validation approaches.
Review and approve system lifecycle documentation to ensure compliance with SOPs and regulatory requirements.
Support internal audits and regulatory inspections (FDA/EMA).