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Senior Computer System Validation (CSV) Quality Engineer at Valspec - ApplyBlast

Senior Computer System Validation (CSV) Quality Engineer

Valspec

2 months ago

San Diego, California, United States

Onsite

Contract

Senior

0 applicants

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About this role

The Senior CSV Quality Engineer will provide quality assurance oversight and technical validation expertise for computerized systems across laboratory, manufacturing, and quality support functions in a biopharmaceutical environment. The role ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and supports audit readiness, data integrity, and regulatory inspections.

Responsibilities

Provide quality assurance oversight for computerized systems
Review and approve validation lifecycle documentation
Support internal audits and regulatory inspections as subject matter expert

Skills

Qualifications

Bachelor's degree in a relevant scientific, engineering, or technical discipline

About Valspec

valspec.net

Headquarters

Royersford, Pennsylvania, United States

Company Size

51-200 employees

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Valspec is a digital lifecycle services company for the life sciences industry, specializing in end-to-end implementation, qualification, and validation of enterprise software, IT/OT infrastructure, and manufacturing systems. With 25 years of experience, they offer services spanning CSV/CSA, CQV, data governance and integrity, eVLM implementation, and AI-driven digital solutions. Valspec helps pharmaceutical, biotech, and related clients achieve regulatory compliance and inspection readiness across the full system lifecycle.