CSV Engineer

Raritan, NJ, US • Posted 30+ days ago • Updated 7 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

Regulatory Compliance
SAP ERP
MES
Manufacturing
Traceability Matrix
System Testing
Acceptance Testing
Scripting
Design Review
Test Plans
Test Scripts
JIRA
SAP Solution Manager
Management
Collaboration
Offshoring
Software Development Methodology
Computerized System Validation
GxP
Communication
Supervision

Summary

Job Summary:

The CSV Engineer will be responsible for validating ERP, SAP, and MES manufacturing applications in a regulated environment.
The role involves ensuring compliance with GxP standards through risk-based validation, supporting multiple projects, and providing validation guidance while working collaboratively with cross-functional and remote teams.

Roles & Responsibilities:

Validate ERP, SAP, and MES manufacturing applications.
Perform computer system validation activities following SDLC and risk-based validation approaches.
uthor, review, and execute validation deliverables including requirements, validation plans, test protocols, traceability matrices, test summary reports, and validation reports.
Review system testing and user acceptance testing (UAT) scripts, design specifications, and change records.
Design, review, approve, and execute test plans, test scripts, and test procedures.
Execute test scripts, review defects, and support defect resolution.
Utilize tools such as JIRA, SAP Solution Manager, XRAY, and support change record reviews.
Provide validation guidance, timely reviews, and escalations to TQ management.
Collaborate with onshore and offshore teams and support multiple changes or projects simultaneously.
Communicate validation status, risks, and issues effectively.

Education & Experience:

Minimum 3+ years of experience with System Development Life Cycle (SDLC).
7+ years of experience in Computer System Validation (based on role level).
Experience working in FDA and/or globally regulated environments with strong knowledge of GxP standards and risk-based validation.
Strong verbal and written communication skills.
bility to work independently, as part of a team, or lead tasks with minimal supervision.

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: 3259ce3b3df40d1526b54a5de3d014d9
Posted 30+ days ago

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CSV Engineer

Dice Job Match Score™

Job Details

Skills

Summary

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