Senior Computer System Validation Consultant

Senior Computer System Validation Consultant ROCGJP00039854

• Hourly pay: $75/hr
• Worksite: Leading biotechnology company (San Diego, CA 92121 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment

A leading biotechnology company is seeking a Senior Computer System Validation Consultant for their clinical-stage biopharmaceutical facility that creates next-generation cell and gene therapies with the capacity to cure, making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. The Consultant will lead the enhancement and maintenance of the site's Computer System Validation (CSV) program, providing critical Quality Assurance oversight and technical validation expertise for all computerized systems.

Senior Computer System Validation Consultant Responsibilities:

• Ensure that all IT and automated systems—ranging from laboratory and manufacturing to quality support—are implemented, validated, and maintained in full compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 standards.
• Act as the Quality Lead for project teams, guiding validation activities throughout the system lifecycle and ensuring inspection readiness for all computerized systems.
• Author, review, and approve critical validation deliverables, including: Validation Plans, Risk Assessments, and User Requirements Specifications (URS),Configuration Specifications, Design Specifications, and Traceability Matrices, Test Scripts (IQ/OQ/PQ) and Validation Summary Reports
• Perform requalification of existing computer systems and support Periodic System Reviews to maintain a validated state.
• Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.
• Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.
• Provide expert guidance to project teams on compliance and security control requirements to ensure data integrity and system reliability are integrated by design.
• Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.
• Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
• Support evaluation of existing legacy systems for technical integration and tool management.
• Advise on the implementation of compliance and security controls for both new and existing systems.

Senior Computer System Validation Consultant Qualifications:

• 8+ years of experience in the Life Sciences industry (Consulting or Industry) with a focus on Computer System Validation and Quality Compliance.
• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
• Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820, EU EudraLex Volume 4 (Annex 11 and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data integrity frameworks
• Strong IT/technical background with the ability to understand the complexities of networked programs and infrastructure.
• Familiarity with laboratory, manufacturing, and quality management systems for GMP operations, including: Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES)
• Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
• Experience developing training materials and delivering training to employees on CSV topics.
• Ability to lift up to 20 pounds as needed.

Shift:

• Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.

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