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CSV Engineer || Raritan, NJ - Hybrid(Day1 Onsite) ||NEED LOCALS at Raritan, New Jersey, USA
Email: [email protected]
Greetings from 
ICONIC Infosys Inc

!!

ICONIC Infosys Inc

is an IT Development & IT Staffing firm with more than a decade of experience in providing IT Staffing Solutions & Services. Our expertise is in sourcing and deploying highly skilled IT Specialists into mainstream and niche technologies to meet clients Temporary, Permanent & SOW project needs.

Role: CSV Engineer

Location: Raritan, NJ Hybrid(Day1 Onsite)

Duration: Long term

Mandatory skills:

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

Best Regards
,

Sai Krishna

Technical Recruiter

Email:
[email protected]

www.iconicinfosys.com

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Keywords: information technology New Jersey
CSV Engineer || Raritan, NJ - Hybrid(Day1 Onsite) ||NEED LOCALS
[email protected]
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Mon Apr 15 19:12:00 UTC 2024

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Location: Raritan, New Jersey