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    Sr. Computer Systems Validation Engineer - Wilmington, United States - The ACI Group

    The ACI Group
    The ACI Group Wilmington, United States

    1 week ago

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    Description
    About the job Sr. Computer Systems Validation Engineer

    Sr. Computer Systems Validation Engineer, Remote
    Contract
    Remote
    Due to our government client requirements, we can only consider US Citizen or Green Card holders for this position


    NO THIRD PARTY RECRUITERS PLEASE

    KEYWORDS:
    Pharmaceutical, Computer Systems Validation

    Description

    Seeking a Sr. Computer Systems Validation Engineer to develop Computer System Validation strategies for testing/validation support for clients located throughout North America.

    Responsibilities

    Support in building CSV strategy for a newly developed computer system from scratch.
    Prepare testing (without any previous versions); write test cases.
    Collaborate on CSV change control and documentation for a Cloud Implemented System.

    Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.

    Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability matrix, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.

    Initiate/update GxP and Risk Assessments on system.
    Author, review and or approve scheduled periodic reviews.
    Author, initiate, and/or review and approve IT SOPs related to compliance.
    Manage GxP projects across pharmaceutical, biotech and medical device systems such as ERP, LIMS, MES, CDMS, BMS, etc.
    Manage and supervise teams.

    Requirements


    BS degree in Computer Science, IT, Biomedical, Pharmaceutical, Chemical or any other variety of engineering with years of experience in Information Technology and computer system Compliance and/or Validation.

    5-10 years experience in FDA regulated environment with strong understanding of cGxP standards and Risk based validation.
    Hands-on experience developing requirements, test cases and procedures.
    Experience with Lab equipment and Systems, LIMS, GLP or GMP, and knowledge of data integrity.
    Knowledge of regulatory guidance's and industry standards (i.e., Quality Systems, GAMP, 21 CFR Part 11, Annex 11, ISO)

    Experience in developing or reviewing system Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices and Validation Summary Reports.

    Expertise in generating, reviewing, and addressing CAPAs.
    Practical experience with Data Integrity and ALCOA+.
    Competency with Project Management practices and techniques.
    Strong attention to detail.
    Experience with local and Cloud Implemented Systems.
    Great interpersonal skills.
    Excellent communication skills, written and verbal.
    Experience with pharmaceutical, biotech and medical device systems such as ERP, LIMS, MES, CDMS, BMS, etc.

    Desired

    Prefer experience in some of the following focus areas:
    ERP -

    NetSuite , SAP, MS Dynamics, other ERP Applications
    EDC -

    REDCap , Medidata, other EDC applications
    LIMS -

    LabCollector, Freezerworks , Labware, other LIMS application
    Chromatography -

    Analyst , Empower, OpenLab, Chromeleon Other Chromatography Systems
    Lab Systems -

    MDS, SoftMax, Quant Studio , general QC Laboratory Equipment Validation
    Other -

    VisioPharm


    Please Note:
    Only those individuals selected for an interview will be contacted.
    No calls, inquiries, or Third-Party Vendors please.
    We are an equal opportunity employer (Unable to sponsor H1B Visas).
    $1000 Referral Bonus -


    Since 1988, The ACI Group, a Baltimore-based staffing firm, has been committed to hiring the industry's leading professionals, and presenting exciting career opportunities.

    We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.

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