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CSV Engineer

Raritan, NJ, US • Posted 60+ days ago • Updated 2 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Inventory
Test Plans
Scripting
Regulatory Compliance
Leadership
Collaboration
Pharmaceutics
Medical Devices
Computerized System Validation
Enterprise Resource Planning
Data Migration
Cloud Computing
Migration
Acquisition
GxP
Documentation
URS
IQ
OQ
PQ
Acceptance Testing
Traceability Matrix
Test Methods
Management

Summary

Roles & Responsibilities

Lead end-to-end CSV activities (inventory assessment remediation disposition)
Support business separation for large GxP systems
Define & implement risk-based validation strategies
Review & approve test plans, UAT scripts, validation documents
Ensure compliance with regulatory & quality standards
Provide guidance, escalation & leadership to validation teams
Collaborate with global & remote teams

Education & Experience :

7-10 years in CSV / Validation roles
Experience in Pharma / Biotech / Medical Devices industry
Proven experience in regulated environments (FDA/GxP)
Strong expertise in CSV (Computer System Validation) in GxP environments
Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
Hands-on in Acquisitions / Divestitures / Business Separation projects
Deep understanding of FDA regulations & GxP standards
Experience with Risk-based validation approach
Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
Experience in UAT, Traceability Matrix & QA methodologies
bility to lead teams & manage multiple projects

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 581401294838ed93edbcff2023f0e4c9
Posted 30+ days ago

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