CSV Engineer (Computer System Validation)
Job Description
Job Title: CSV Engineer (Computer System Validation)
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Location: Raritan, NJ – 3 Days Onsite
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Job Summary
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We are looking for an experienced Computer System Validation (CSV) Engineer with a background in pharmaceutical, biotechnology, medical device, or life sciences environments. The ideal candidate will have strong knowledge of GxP compliance, FDA regulations, 21 CFR Part 11, and GAMP 5, along with hands-on experience validating regulated computerized systems.
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Key Responsibilities
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• Plan and execute computer system validation activities in regulated life sciences environments.
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• Develop and maintain validation documentation, including validation plans, risk assessments, requirements specifications, test protocols, and validation summary reports.
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• Validate computerized systems such as ERP, LIMS, MES, QMS, SaaS applications, and laboratory systems.
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• Ensure compliance with GxP requirements, FDA regulations, 21 CFR Part 11, and GAMP 5 guidelines.
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• Perform risk-based assessments, system testing, deviation management, and issue resolution.
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• Support system implementation, upgrades, change control, and periodic reviews.
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• Collaborate with IT teams, Quality Assurance, business stakeholders, and system owners.
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• Maintain audit-ready documentation and ensure data integrity throughout the system lifecycle.
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• Support internal and external audits and regulatory inspections as required.
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Required Skills & Qualifications
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• 10+ years of Computer System Validation (CSV) experience.
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• Experience in pharmaceutical, biotechnology, medical device, or life sciences environments.
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• Strong understanding of GxP, FDA regulations, 21 CFR Part 11, and GAMP 5.
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• Hands-on experience validating ERP, LIMS, MES, QMS, SaaS, or laboratory systems.
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• Knowledge of validation lifecycle documentation, risk assessments, test execution, deviations, and change control.
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• Excellent documentation, communication, analytical, and stakeholder management skills.
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• Ability to work onsite in Raritan, NJ, three days per week.