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Analog Engineer Jobs in New Jersey

CSV Engineer

Katalyst Healthcares & Life Sciences

  • Raritan, NJ
  • 30+ days ago

    Highlights

    Summary: Roles & Responsibilities: Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.

    Numbers & Facts

    LocationRaritan, NJ

    Description

    Summary :

    Roles & Responsibilities :
    • Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
    • Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
    • Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
    • Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
    • Demonstrated application of risk-based validation and risk management practices.
    • Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
    • Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
    • " Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
    • Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
    • Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
    • Primary Language required: English. Strong verbal and written communication skills.
    • Ability to work with dispersed/remote teams and support several projects simultaneously.
    • Experience with Acquisitions/Separations/ Divestiture efforts is desirable.

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