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    Validation Engineer, Labware LIMS - Foster City, United States - I.T. Solutions

    I.T. Solutions
    I.T. Solutions Foster City, United States

    4 weeks ago

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    Description

    Validation Engineer, Labware LIMS

    Foster City, VA

    Length: year to start, likely extensions

    Responsibilities

    • Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
    • Develop Validation testing strategy in accordance with Gilead's policy and procedures
    • Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
    • Assist with understanding the business requirements, analyze and help translate into functional requirements for assigned LIMS projects
    • Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
    • Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
    • Responsible for Qualification protocols execution and final report view and approval for LIMS projects
    • Perform "Data Integrity related- risk assessments,
    • Deviation investigations suggest implementing remediations in CGMP operations.
    • Performs Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.
    • Collaborates with the external partner or internal site to assess their DI maturity state and document the results of the assessment.

    Required Experience / Skills:

    • Minimum of 6-10+ years of experience (Hiring for multiple roles Junior, Mid and Senior levels) working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
    • Advanced knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.
    • Ability to master technical content through interaction with subject matter experts.
    • Effective communication and interpersonal skills.
    • Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
    • Understanding of programming and relational database concepts is required.

    Required Education:

    • BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
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