CSV Engineer

Raritan, NJ, US • Posted 9 days ago • Updated 12 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Documentation
Regulatory Compliance
Traceability Matrix
Test Methods
Test Plans
System Testing
Acceptance Testing
Scripting
Test Scripts
JIRA
ServiceNow
Management
Communication
Supervision
Windchill
Product Lifecycle Management
Plant Lifecycle Management
Computerized System Validation
Software Development Methodology
GxP

Summary

Job Summary:

The CSV Engineer will be responsible for validating Windchill and Product Lifecycle Management (PLM) systems in an FDA and/or globally regulated environment.
This role requires strong knowledge of GxP standards, risk-based validation, and Computer System Validation (CSV) practices, along with the ability to support multiple projects in a hybrid work environment.

Roles & Responsibilities:

Validate Windchill and Product Lifecycle Management (PLM) systems in regulated environments.
Write, review, and execute validation documentation including requirements, compliance/validation plans, test protocols, test summary reports, and validation reports.
Review system test scripts, user acceptance test (UAT) scripts, traceability matrices, and design specifications.
Apply QA methodologies while designing, reviewing, and approving test plans, system test scripts, UAT test scripts, and test procedures.
Execute test scripts, review defects, and support defect resolution activities.
Use tools such as JIRA, qTest, ServiceNow, XRAY, and perform change record reviews.
Provide validation guidance, perform timely document reviews, and escalate issues to TQ management as needed.
Work collaboratively with onsite and remote teams while supporting multiple changes and projects simultaneously.
Demonstrate strong verbal and written communication skills.
Work independently, as a team player, or lead validation activities with minimal supervision.

Experience:

3+ years of experience validating Windchill and Product Lifecycle Management (PLM) systems.
7+ years of experience in Computer System Validation (CSV) and System Development Life Cycle (SDLC).
Experience working in FDA and/or globally regulated environments.
Strong understanding of GxP standards and risk-based validation approaches.

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: 9ffef467f6112c6d07a08a16524a884f
Posted 9 days ago

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CSV Engineer

Dice Job Match Score™

Job Details

Skills

Summary

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