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Senior Validation CSV at Genezen - ApplyBlast

Senior Validation CSV

Genezen

1 month ago

3.5 on Glassdoor

Lexington, Massachusetts, United States

Onsite

Full Time

Senior

0 applicants

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About this role

The Senior Validation CSV role leads risk‑based validation projects for GxP computerized systems, prepares and reviews qualification documentation, and supports data integrity initiatives. The incumbent collaborates with cross‑functional teams to ensure compliance with FDA, EU, ISO, and internal standards while driving best‑in‑class validation practices.

Responsibilities

Lead risk‑based validation strategies for GxP computerized systems
Review and approve qualification documentation to ensure regulatory compliance
Provide CSV and data integrity expertise during audits, vendor selection, and change controls

Skills

Qualifications

Bachelor's degree in Engineering or Computer Science

About Genezen

genezen.com

Headquarters

Lexington, Massachusetts, United States

Company Size

51-200 employees

Founded

2014

View Profile

Genezen is a contract development and manufacturing organization (CDMO) focused on viral vector production to accelerate gene and cell therapies. It provides expertise, GMP-capable facilities, and end-to-end capabilities to support process development, scale-up and commercial manufacturing for advanced biologics. Genezen positions itself as a partner to biotech and pharma teams, offering quality systems, analytical support, and manufacturing capacity to shorten timelines and reduce development risk.