Computer System Validation(CSV) Manager Job at Catalyst Life Sciences, Philadelphia, PA

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  • Catalyst Life Sciences
  • Philadelphia, PA

Job Description

Join a cutting-edge biotech company at the forefront of scientific innovation in the cancer space! We're seeking a Computer System Validation (CSV) Manager to lead and manage all validation activities across our GxP-regulated systems.

Key Responsibilities:

  • Oversee CSV lifecycle for lab and manufacturing systems
  • Ensure compliance with FDA, GAMP 5, and 21 CFR Part 11
  • Collaborate with QA, IT, and system owners for audits and inspections

Qualifications:

  • 5+ years in CSV within life sciences
  • Strong understanding of GxP, data integrity, and regulatory requirements
  • Excellent communication and project management skills

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