CSV Engineer

Raritan, NJ, US • Posted 30+ days ago • Updated 9 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

📊 Calculating match score...

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 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

CSV Engineer

South Plainfield, New Jersey

•

Today

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Full-time

IT CSV Engineer(Hybrid)

New Jersey

•

Today

IT CSV Engineer (Hybrid) Location: Somerset,NJ Interview:Phone+Skype most important skillset is experience with Snowflake and AI. The IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating Snowflake Data Lake platforms and AI interfaces, ensuring compliance with regulatory requirements and data integrity standards. IT CSV Engineer Responsibilities: A

Easy Apply

Contract, Third Party

Validation Lead Raritan - NJ - New Jersey

Raritan, New Jersey

•

Today

Job Title: Validation Lead with AI knowledge Location: Raritan, NJ Remote for Canada Type: Contract Role Descriptions: Demonstratable Experience in Computer System Validation (CSV)Experience in software development processes (SDLC) and software testing life cycle (STLC) Experience in drafting reviewing revising and maintaining validation documents (CSV) including Compliance Analysis Compliance Plan Change Control Document User Functional Requirement documents Risk Assessments (Risk Register) T

Third Party, Contract

Depends on Experience

Scientist II (HPLC Method Validation)

Lebanon, New Jersey

•

Today

Shift: Monday through Friday, 8:30 AM - 5:00 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. This is an onsite full-time Raw Materials Scientist II position located in Lebanon, NJ The primary focus of this position will be performing HPLC method validations in a GMP environment. Monday - Friday, from 8:30

Full-time

Search all similar jobs