Job Title: CSV Engineer
Location: Raritan, NJ(Hybrid)
• Experience in validating ERP/SAP/ MES Manufacturing applications
• 3+ years’ experience with System Development Lifecyle 7+ years’ experience in Computer System Validation (Based on the role selected)
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Preferred tools knowledge and experience: JIRA, SAP Solution Manager, XRAY and Change Record review
• Should be experienced in Test scripts, executions and defect reviews.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Location: Raritan, NJ(Hybrid)
Mandatory – Validation experience with ERP applications / SAP / MES
Job Description:
• Experience in validating ERP/SAP/ MES Manufacturing applications
• 3+ years’ experience with System Development Lifecyle 7+ years’ experience in Computer System Validation (Based on the role selected)
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Preferred tools knowledge and experience: JIRA, SAP Solution Manager, XRAY and Change Record review
• Should be experienced in Test scripts, executions and defect reviews.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
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Thanks & Regards
Deepali Chadha
HMG AMERICA LLC
E: Deepali@hmgamerica.com
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