Job Details

ID #54126744
Estado Massachusetts
Ciudad Newton
Tipo de trabajo Contract
Fuente Katalyst Healthcares & Life Sciences
Showed 2025-07-07
Fecha 2025-07-07
Fecha tope 2025-09-05
Categoría Etcétera
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Computer System Validation (CSV) Engineer

Massachusetts, Newton
Aplica ya

Responsibilities:Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices.Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.Support system implementations, upgrades, and periodic reviews.Collaborate with QA, IT, and business users to drive validation strategy.Participate in audits and inspections to demonstrate compliance.Requirements:Bachelor's degree in computer science, Engineering, Life Sciences, or related field.2+ years of hands-on CSV experience in pharma, biotech, or medical device environments.Strong working knowledge of GxP, FDA regulations, and SDLC methodologies.Experience validating cloud-based or SaaS GxP systems is a plus.Excellent documentation, communication, and collaboration skills.

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