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    Process Validation Engineer - Austin, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Austin, United States

    3 weeks ago

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    Description

    Responsibilities:
    Defines validation strategy and requirements and ensure implementation.


    Review and approve validation requirements, master validation plan/report, validation protocols/ reports to support Process Validation and re-validation activities for New Product Introduction and Sustaining in accordance with FDA/AAMI/ISO/EN guidelines/standards.

    Actively participate during all phases of process qualification.


    Evaluate projects, provides guidance and technical information to others to generate protocols, execute qualification activities, analyze resulting data and to prepare reports.

    Lead and assist in all assigned qualification activities.

    Determine and establish requirements for qualification activities.

    Make independent decisions related to qualification activities.

    Participate in the generation and/or update of the validation plan and validation status lists.

    Review qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.

    Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.

    Bring critical exceptions or deviations to management's attention and propose compliant solutions.

    Lead trouble shooting activities for deviations and non-conformances

    Recommend to management as to the acceptance and release of qualified systems.

    Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.


    Requirements:
    Write and revise standard operating procedures describing validation principles and activities.

    Provide training and guidance to applicable operators and technicians

    Initiate, execute, and track completion of Change Control requests.

    Establish priorities and schedule activities to ensure timelines and milestones are met.

    Participate in external audits of providers and labs.

    Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products

    Responsible for establishing validation standards

    Coordinate with required personnel affected by validation testing

    Review and approve validation execution reports, and associated deviations

    Analyzes test results

    Reviews and prepares compliance reports

    Directs validation activities

    Resolves testing problems

    Makes adjustments or improvements to equipment and processes

    Creates databases to track validation activities

    Interprets customer requirements

    Develops validation schedules

    Conducts training and overseeing the work of validation technicians

    Keeps up to date on industry standards and regulations.

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