What are the responsibilities and job description for the CSV Engineer position at Noblesoft Technologies?
Role CSV Engineer
Location Raritan NJ (Hybrid 3 days onsite)
Must Have : The resource must have experience in Tool validation ServiceNOW JIRA Automation tools
Job Details :
37 years experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
Has working experience in any one or two of the following domains Tool validation like ServiceNOW Automation tools JIRA
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 guidances 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
Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification / User Stories Criticality Assessment Test Plan Design Documentation Validation Plan Risk Assessment Validation Strategy / Test Planning Validation / Test Summary Requirement Trace Matrix.
Possesses strong communication skills to interact with business stake holders (Technology Leader Project Manager Business Owner
Ability to work with project team to facilitate interaction between Project team and Business Stake holders
Ability to manage and provide guidance / train the team on Policies end to end SDLC Process Procedure and Tools
Trains the project team on the relevant procedures associated with different SDLC processes and Tools
Strong in Project Management tools like JIRA
Manage Project priorities based upon identified risks.
