CSV Engineer(Kneat e-validation) – Automation Systems

Jersey City, NJ, US • Posted 2 days ago • Updated 2 days ago

Contract W2

Contract Independent

Contract Corp To Corp

No Travel Required

On-site

Depends on Experience

Fitment

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Job Details

Skills

Data Integrity
GMP
OQ
URS

Summary

Computer System Validation (CSV) Engineer

Location :: New Jersey

Duration :: Contract

Job Description:

Role Summary

Seeking an experienced Computer System Validation (CSV) Engineer to support GMP manufacturing systems. The role includes qualification of Rockwell PLCs, HMIs, and servers using the Kneat

e-validation platform, ensuring compliance with ALCOA+ and regulatory standards.

Key Responsibilities

Execute CSV lifecycle activities (URS, Risk Assessment, IQ/OQ/PQ, VSR).
Qualify Rockwell PLC, HMI, and server-based systems.
Use Kneat for validation documentation and execution.
Ensure compliance with ALCOA+, 21 CFR Part 11, and GAMP 5.
Support audits, change control, and deviation management.

Requirements

5+ years of CSV experience in pharma/GMP environment.
Hands-on Kneat e-Validation platform experience -mandatory
Experience qualifying Rockwell PLC, HMI, and server systems.
Strong understanding of ALCOA+ data integrity principles.
Excellent knowledge on Process validation in phama industries
Good Knowledge working on IQ,OQ and PQ testing and documentation

Thanks,

Abdul Samad

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: 10122703
Position Id: 8908744
Posted 2 days ago

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