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    Senior Validation Engineer - Broomfield, United States - Gahagan & Bryant Associates Inc

    Gahagan & Bryant Associates Inc
    Gahagan & Bryant Associates Inc Broomfield, United States

    3 weeks ago

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    Description
    Senior Validation Engineer


    COMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities.

    We are seeking an experienced Senior Validation Engineer to join our growing team. COMPI differentiates itself through an integrated approach to engineering, construction commissioning and validation.


    Responsibilities:
    Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects
    Prepare and execute commissioning / validation lifecycle documents
    Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
    Write summary reports for validation and qualification protocols
    Support project milestones, priorities and deadlines
    Write operating procedures for technical equipment and practices and procedures
    Perform system and process risk assessments and analyses
    Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management
    Develop project specific validation plans and strategy
    Able to manage and execute multiple projects to meet client's priorities
    Provide a practical approach to problem solving
    Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers


    Requirements:
    Bachelor's degree in a related life sciences or requisite industry training and experience

    • 10 years GMP experience
    Aseptic process experience preferred
    Critical utility experience preferred
    Ability to converse about scientific matters
    Ability to work independently or in collaboration with others
    In depth understanding and application of validation principles, concepts, practices and standards
    Proficient in current Good Manufacturing Practices and other applicable regulations

    Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g.

    , URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
    Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
    Excellent written communication skills with emphasis in technical writing
    Proficient in Microsoft Word, Excel, Power Point and Projects
    Salary range is 85-175K, depending on experience level


    On the job training will be provided by the validation team and manager, and through industry training and certification courses, both online and in person.

    All candidates must be legally eligible to work in the United States.

    Just be willing to travel regionally and / or nationally throughout the U.S.

    We are an equal opportunity employer M/F/D/V

    COMPI does not accept unsolicited resumes from recruiters / third parties.
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