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DONT SEND ME HCL SUBMITTED RESUMES :: for CSV Engineer :: Raritan, NJ (Hybrid 3 days onsite) at Raritan, New Jersey, USA
Email: bharadwaj@fisecglobal.net
From:

bharadwaj,

Fisec Global Inc

bharadwaj@fisecglobal.net

Reply to:   bharadwaj@fisecglobal.net

Hi Everyone,

We have an urgent position for below requirement, if you are available and interested, please do reply me with your updated resume to bharadwaj@fisecglobal.net 

Job Title:
CSV Engineer

Location:

Raritan, NJ (Hybrid 3 days onsite)

Duration: Long Term contract

Must Have: The resource must have experience in Tool validation - ServiceNow, JIRA, Automation tools

Job Summary:

     3-7 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..

Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV).

Keywords: New Jersey
DONT SEND ME HCL SUBMITTED RESUMES :: for CSV Engineer :: Raritan, NJ (Hybrid 3 days onsite)
bharadwaj@fisecglobal.net
https://jobs.nvoids.com/job_details.jsp?id=2131648
bharadwaj@fisecglobal.net
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02:27 AM 31-Jan-25


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Location: Raritan, New Jersey