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Computer System Validation – CSV Engineer Job Opening In Montclair – Now Hiring Katalyst HealthCares & Life Sciences


Job description


Roles & Responsibilities:
  • Minimum + years of relevant experience; can work independently and guide/mentor Junior resources.


  • Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.


  • Knowledge of FDA guidance's and industry standards (, GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc.

    Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.


  • Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.


  • Ability to Review Automated Test script Strong verbal and written communication skills.


  • Ability to work as a team player, lead a team or accomplish tasks without supervision.


  • Ability to work with remote teams and support several changes/projects simultaneously.


  • Ability to provide Validation guidance, timely reviews, and escalations to TQ management.


  • Hands on experience with validation of Data Solutions is preferred.


  • Required Skill Profession

    Computer Occupations


    • Job Details

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    Unlock Your Computer System Potential: Insight & Career Growth Guide


    Real-time Computer System Jobs Trends (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Computer System in Montclair, United States, highlighting market share and opportunities for professionals in Computer System roles.

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