Computer System Validation

Role - Computer System Validation - CSV Engineer
Location - Raritan, NJ(Hybrid)
Job Details:

• 7-10 years' experience in Computer System Validation SAP ECC/S4, SolMan/ChaRM Change Control process

• Experienced in computer systems validation, GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation.

• Knowledge in utilizing SDLC tools such as JIRA, qTest, X-ray, test automation tools and methods,

• Proficient knowledge on CFR Part 11 regulations and Quality Management Regulations.

• Proficient with change control management and utilization.

• Authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required Interact with technology partners to ensure compliant working and operation of supported GxP systems

• Experience working in Agile metho ology and tools is required