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    Validation Engineer - Columbus, United States - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Columbus, United States

    3 weeks ago

    Intellectt Inc background
    Description

    Role: Validation Engineer III

    Location: Columbus, OH

    Duration: 12+ Months on W2

    Shift Timings: 8 am to 5 pm

    - 100% Onsite role.

    Skills Looking For:

    The project entails providing validation support for project execution, drafting documentation for FDA compliance related to new processes or packaging equipment, and collaborating with site engineers to detail documents and support execution and sign-off.

    Responsible for drafting various types of documentation necessary for FDA compliance related to new processes or packaging equipment.

    This documentation includes: User Requirement Specifications (URS), Functional Requirements Specifications (FRS), Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validation protocols, and reports.

    Must have validation and document generation experience.

    Familiarity with FDA standards, particularly 21 CFR Part 11.

    Experience in pharmaceutical validation roles is desirable.

    Familiarity with Microsoft Project and M Files is preferred, though training can be provided if necessary.

    Will candidates with experience in IQ, OQ, and PQ writing in a manufacturing or production setting.

    Education and Experience:

    A bachelor's degree in engineering is required, with at least 5 years of experience.

    Top 3 Skills:

    Validation experience

    Document generation and writing exp

    Familiarity with FDA standards and 21 CFR Part 11

    Interview Process:

    Virtual interview followed by an onsite panel interview is preferred. Will consider a second round virtual for those who are not local.

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