Computer System Validation Specialist
Position: Computer System Validation Specialist
Location: Santa Clara, CA (Onsite)
Experience: 4 - 7 Years
Duration: 12+ months Contract
Job Description:
We are seeking a skilled Computer System Validation Specialist with 4 7 years of experience in software quality assurance or software validation, preferably in the medical device industry. The ideal candidate will have strong knowledge of regulatory standards, computer system validation (CSV), and compliance frameworks to support validation activities across development and quality systems.
Key Responsibilities:
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Execute software validation activities in compliance with FDA, ISO, and IEC regulations.
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Perform non-product software validation for development, testing, and maintenance tools.
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Conduct GxP and 21 CFR Part 11 applicability/criticality assessments.
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Prepare, review, and execute validation deliverables, including requirements, validation plans, test protocols, test specifications, traceability matrices, and reports.
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Carry out dry runs and execution of test protocols.
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Perform periodic system reviews and system retirement activities.
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Ensure alignment with medical device quality and compliance standards.
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Support validation in line with GAMP guidelines and computer system development lifecycles.
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Utilize PLM tools for product lifecycle activities.
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Collaborate using JIRA and JAMA software; test automation experience is a plus.
Required Qualifications:
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4 7 years of experience in software quality assurance or software validation (medical device industry preferred).
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Strong understanding of FDA 21 CFR Part 820, ISO 13485, IEC 62304.
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Good knowledge of CSV, GxP, GAMP, and 21 CFR Part 11 guidelines.
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Hands-on experience with PLM tools and computer system lifecycle management.
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Familiarity with JIRA, JAMA, and test automation (preferred).
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