CSV Engineer

Job Description:

• 6+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance’s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules, requirements, and documents
• This resource will support the following related to our Service Industrialization (SI) project Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets Design and set up Mapping Structure for TS Services in SharePoint List Record the technologies from the excel spreadsheets in the Mapping Structure for each Service
• Collect the CMDB information for each technology pulled from the spreadsheets Analyze technologies collected manually for GxP classification
• Analyze hierarchy and data attributes for Services Set up reporting to communicate status of progress Services supporting GxP use cases Services' technologies identified Services' technologies CMDB GxP classification status