CSV Engineer
Share
Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: CSV Engineer
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.
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.
Key Skills
- ASP.NET
- Health Education
- Fashion Designing
- Fiber
- Investigation
