CSV Engineer- Remote Position - Through HCL America

[Gautam Sharma]

Hello,

 

I hope you are doing well,

I have an urgent role for a CSV Engineer- Remote Position. If any candidate is interested, then please share an updated resume.

 

Role: CSV Engineer

Location: Raritan, NJ – Hybrid

 

Mandatory 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 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

 

--- 

Regards,

 

Gautam Sharma

Sr. Technical Recruiter