CSV Engineer(Kneat e-validation) – Automation Systems

Somerset County, NJ - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Role: CSV Engineer

Location: Branchburg NJ (Onsite)

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 IQOQ and PQ testing and documentation

Role: CSV Engineer Location: Branchburg NJ (Onsite) 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...