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    Validation Engineer - Jacksonville, United States - Diverse Lynx

    Diverse Lynx
    Diverse Lynx Jacksonville, United States

    4 weeks ago

    Default job background
    Description

    Required Skills:
    Previous experience working with software validation and compliance activities in a GXP regulated medical device / biopharmaceutical environment; in one or more of these areas:

    o

    IT Enterprise software

    Ability to work within a global team and handle multiple priorities effectively.

    Knowledge of Systems Development Lifecycle (SDLC) as it applies to computer software for FDA regulated industry.


    Thorough knowledge of US 21 CFR Part 820 and 21 CFR Part 11 regulations, ISO13485, EU Annex 11, FDA and international Data Integrity Guidelines, and FDA s General Principles of Software Validation.

    Expertise with Agile and Waterfall software development & testing methodologies.

    Excellent understanding and application of principles, concepts and practices of Risk Management, Validation, Root Cause Analysis/Failure Investigation.

    Excellent written and verbal communication, interpersonal, conflictmanagement, and organization skills.


    Highly Desirable Skills:
    Experience performing computerized systems periodic validation reviews in GXP regulated industry.

    Knowledge of Corrective and Preventive Actions (CAPAs) in FDA regulated industry.

    Relatable knowledge of FMEA and risk management

    Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination.

    All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role.

    We promote and support a diverse workforce across all levels in the company.

    #J-18808-Ljbffr
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