Computer System Validation Engineer

Katalyst HealthCares and Life Sciences

• $110K — $130K *
Wilmington, DE 19805In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor of Science, Bachelor of Technology, or Bachelor's in Pharmacy required.
  • 8+ years of overall experience in related fields.
  • Minimum of 5 years in Computer System Validation (CSV) for GxP systems.
  • Familiar with compliance standards such as 21 CFR Part 11/820, ISO 9001, and ITIL.
  • High-level understanding of Veeva Vault and its applications.

Responsibilities

  • Conduct audits and inspections for compliance with regulatory standards.
  • Author User Requirement Specifications (URS), Functional Specifications (FS), and validation reports.
  • Implement risk-based testing strategies in accordance with CSA fundamentals.
  • Manage Deviation/CAPA processes and ensure SOP compliance.
  • Review access rosters and audit trails to maintain data integrity.

Benefits

  • Comprehensive health insurance package.
  • Opportunities for continued education and professional development.
  • Flexible work hours to support work-life balance.
Full Job Description
Roles & Responsibilities :
  • 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
  • uthoring of URS/FS, protocols, final reports, validation plan/report
  • High-level understanding of Veeva Vault suits
  • Risk-based testing aligned to CSA fundamentals
  • High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

Education & Experience :
  • Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
  • Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
* Ladders Estimates

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