CSV Consultant

Katalyst HealthCares & Life Sciences

Full-time Framingham, Massachusetts Computer Occupations

Posted:

March 03, 2026

Location:

Framingham, Massachusetts, United States

Job Description

 Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring compliance with FDA and global regulatory standards. 
  Roles & Responsibilities: 
 Validate SaaS and enterprise systems (Oracle Fusion Cloud ERP, serialization systems, eQMS, EBR) 

 Perform CSA-based validation, release impact assessments, and system integrations 

 Execute IQ/OQ/PQ for manufacturing and lab equipment 

 Author and execute validation documents (URS, FRS, IQ/OQ/PQ, RTM, VSR) 

 Ensure compliance with CFR Part , GAMP , Annex , and data integrity 

 Support audits, inspections, change controls, deviations, and CAPAs 
  Education & Experience : 
 Bachelor's degree in Engineering, Life Sciences, or related field 

 –+ years of CSV experience...
                

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Job Overview

Job Type: Full-time

Location: Framingham, United States

Posted: March 03, 2026

Deadline: April 12, 2026