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Looking for CSV Engineer || Raritan, NJ Hybrid at Raritan, New Jersey, USA
Email: [email protected]
Hi Folks,

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doing well.

Please share
your interest on the below position.

Position: CSV Engineer

Location: Raritan, NJ Hybrid

Job
Description

Keywords

CSV, Computer
System Validation, SAP Validation, ERP systems, MES, IT CSV, Manufacturing
systems, Lab systems

Roles and
Responsibilities

           
2-4  years Experience in Validating MES or Manufacturing an Lab systems

           
Experienced in CSV activities in Manufacturing related applications like SAP
Systems, MES systems or Lab related systems in the manufacturing space

           
Perform review for GxP systems to ensure compliance with regulatory
requirements

           
Working knowledge on end-to-end validation of GxP applications and is able to
perform document/process Compliance Analysis

           
Adept with Agile and Waterfall methodology-based software development
Compliance and has prior experience in Computer System Validation using Agile
methodology

           
Reviews - Requirement Specifications, Functional Specifications/ User Stories /
Acceptance Criteria and ensures completeness of test script with traceability

           
Ensures Risk Assessment is completed for all the requirements and test cases
are designed in reference to the risk levels identified for the requirements

           
Performs review of pre-executed test protocol which includes all the basic
elements of a test script, completeness and appropriateness of the test case to
the requirement

           
Ensures pre-executed test protocol has the necessary test data requirements to
run the tests

           
Reviews post-executed test protocols for the completeness, accuracy of the
results and evidence and enables team on the defect management process

           
Able to author Validation Plan and compile Validation Summary Report and
generates RTM

           
Reviews and ensures that the Operational Procedure for the application is ready

           
Is able to handle Change Requirement related implementation for small changes -
responsible for Implementation Plan, Impact Assessment, Test Plan/ Results,
Defects and RTM

Prior experience
in using tools like ALM, DMS and JIRA

Thanks, and Regards

Himanshu Sharma | Talent Acquisition Specialist

Amaze Systems Inc.

USA:

8951 Cypress Waters Blvd, Suite 160,
Dallas, TX 75019

D
: +1 (669) 305-7733

LinkedIn:
https://www.linkedin.com/in/sahab18/

E:
[email protected]
|
www.amaze-systems.com/

USA | Canada | UK | India

Amaze Systems is an Equal Opportunity Employer (EOE), and
does not discriminate based on age, gender, religion, disability, marital
status, race and also adheres to laws relating to non-discrimination on the
basis of national origin and citizenship status.

--

Keywords: information technology New Jersey Texas
Looking for CSV Engineer || Raritan, NJ Hybrid
[email protected]
[email protected]
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Mon Apr 15 20:29:00 UTC 2024

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Location: Raritan, New Jersey