Job Opening || CSV Engineer – Raritan, NJ(Hybrid 3 days a week)

Hello,

My name is Adarsh Nandi, and I work as a Technical Recruiter for K-Tek Resourcing.
 
We are searching for Professionals below business requirements for one of our clients. Please read through the requirements and connect with us in case it suits your profile.


Please see the Job Description and if you feel Interested then send me your updated resume at [email protected] or give me a call at  832.660.0933. 


Job Title:  CSV Engineer
Location:  Raritan, NJ(Hybrid 3 days a week)
Duration: Long Term
Job Description:
  • Skills- Computer System Validation, GxP Regulations
  • SS- Validating Lab Information Management System – LIMS, LIMS Rollover
  • JD-7-10years’ experience in Computer System Validation of Lab Information Management System – LIMS
  • 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 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
  • Expertise in documentingguiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation StrategyTest Planning, ValidationTest 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.

Thanks & Regards

Adarsh Nandi | LinkedIn
US IT Recruiter | KTEK Resourcing
832-660-0933 | [email protected]

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