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Senior Computer System Validation (CSV) Consultant
Job Location:
Job Location:
San Diego, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
24 May 2026 (30+ days ago)
Posted:
Application Deadline:
21 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
Job Duration: Long Term Contract (Possibility Of Extension)
Pay Rate: $75/hr - $85/hr on W2 DOE
Company Benefits: Medical Dental Vision Paid Sick leave 401K
We are seeking an experienced Senior Computer System Validation (CSV) Consultant to support and enhance the sites Computer System Validation program. This 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.
Key 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).
Qualifications
Bachelors 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.
If interested please send us your updated resume at /
Required Skills:
IQ/OQ/PQ Computer System Validation FDA 21 CFR Part 11
