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CSV Engineer

Job

United Consulting Hub

Woburn, MA (In Person)

Full-Time

Posted 5 days ago (Updated 1 day ago) • Actively hiring

Expires 7/22/2026

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Job Description

CSV Engineer at United Consulting Hub CSV Engineer at United Consulting Hub in Woburn, Massachusetts Posted in about 23 hours ago.
Type:
full-time
Job Description:
We are seeking a CSV Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotech environment.
Key Requirements:
Hands-on experience with Computer System Validation (CSV) Strong understanding of GAMP 5 and 21 CFR Part 11 Experience supporting QC laboratory systems and/or manufacturing equipment validation Ability to develop and review validation lifecycle documents (URS, IQ, OQ, PQ, Risk Assessments, Validation Reports) Experience working cross-functionally with QA, Manufacturing, Engineering, and IT teams Strong documentation and communication skills
Key Responsibilities :
Develop, execute, and maintain CSV documentation and validation protocols for QC and manufacturing systems .Perform risk assessments and ensure compliance with
GAMP 5, 21 CFR
Part 11, and GMP requirements .Review and support validation lifecycle activities, including URS, IQ, OQ, PQ, and validation reports while collaborating with QA, Manufacturing, and IT teams .