Computer System Validation Specialist -- 295382 : ENGINEERING - 295382 at OQSIE
Fremont, CA
About the Job
Support computer system projects as validation manager or CSV designee. Responsible for validation planning and execution in a cross-functional team environment.
Deliverables may include, but are not limited to, authoring of the following documents as needed per project requirements:
User requirements specifications
System design specifications
Configuration Specifications
System administration and operational procedures
Change control records
Validation plans
Functional/Requirements Test Plans and Test Reports
Test Cases
Validation summary reports
Data migration plans and reports
Computer system validation in a GMP environment (preferably in biologics drug manufacturing)
Test case development and execution
Strong experience in computer system design and implementation
Excellent technical writing skills
Ability to work independently
Exceptional collaboration skills
Expert Microsoft Office skills (Word, Excel, PPT, Outlook, Teams, Project, ...)
Experience with content management solutions (documents, requirements, test cases, etc.) as well as paper-based validation processes
Detail-oriented and highly efficient delivery
Deliverables may include, but are not limited to, authoring of the following documents as needed per project requirements:
User requirements specifications
System design specifications
Configuration Specifications
System administration and operational procedures
Change control records
Validation plans
Functional/Requirements Test Plans and Test Reports
Test Cases
Validation summary reports
Data migration plans and reports
Computer system validation in a GMP environment (preferably in biologics drug manufacturing)
Test case development and execution
Strong experience in computer system design and implementation
Excellent technical writing skills
Ability to work independently
Exceptional collaboration skills
Expert Microsoft Office skills (Word, Excel, PPT, Outlook, Teams, Project, ...)
Experience with content management solutions (documents, requirements, test cases, etc.) as well as paper-based validation processes
Detail-oriented and highly efficient delivery