SME Consultant - Winston-Salem - Inteldot

    Inteldot
    Inteldot Winston-Salem

    22 hours ago

    Description
    Position Overview
    We are seeking an experienced Subject Matter Expert (SME) Consultant in LabVantage LIMS to support a major system implementation project for a Life Sciences organization in Winston-Salem, NC. This role will serve as a strategic and functional expert, ensuring the successful configuration, deployment, validation, and adoption of the LabVantage Laboratory Information Management System (LIMS).
    The consultant will collaborate cross-functionally with Quality, IT, Laboratory Operations, and Validation teams to align system capabilities with business and regulatory requirements.
    Key Responsibilities
    • Act as the LabVantage LIMS functional SME throughout the implementation lifecycle.
    • Gather, analyze, and document business and laboratory requirements.
    • Provide expert guidance on system configuration, workflows, data structures, and best practices.
    • Support system design, integration, testing, and validation activities.
    • Review and advise on data migration strategies and execution.
    • Ensure compliance with regulatory standards (GxP, FDA, 21 CFR Part 11, etc.).
    • Partner with project management and technical teams to resolve issues and mitigate risks.
    • Support user acceptance testing (UAT), training, and go-live readiness.
    • Provide post-implementation optimization recommendations.
    Required Qualifications
    • Proven experience as a LabVantage LIMS SME in at least one full implementation.
    • Strong understanding of laboratory workflows within Life Sciences environments.
    • Demonstrated knowledge of system configuration, validation, and regulatory compliance.
    • Experience working with cross-functional stakeholders and technical teams.
    • Ability to translate business needs into functional system requirements.
    • Excellent communication, documentation, and stakeholder management skills.
    Preferred Qualifications
    • Multiple LabVantage implementation or upgrade projects.
    • Experience with integrations (ERP, CDS, ELN, instruments, middleware).
    • Familiarity with data migration tools and strategies.
    • Background in Quality Control or R&D laboratory operations.
    • PMP, CBAP, or similar certification is a plus.
    Work Environment & Travel
    • Onsite presence in Winston-Salem required during key project phases.
    • Remote work possible during planning, documentation, and support phases.
    • Occasional travel may be required depending on project milestones.
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