CSV Engineer

Karwell Technologies • New Wilmington, Pennsylvania, United States

📍 Location

New Wilmington, Pennsylvania

⏰ Job Type

Full-time

📅 Posted

May 10, 2026

About the Role

                    Job Description:   

   Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.  

   Roles & Responsibilities:  

   Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.  

   Ensure audit and inspection readiness.  

   Conduct periodic reviews, access roster reviews, and audit trail reviews.  

   Manage deviations, CAPA processes, SOP, and policy compliance.  

   Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary re...

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