CSV Engineer - Thousand Oaks, United States - Astrix Inc

    Astrix Inc
    Astrix Inc Thousand Oaks, United States

    2 weeks ago

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    Description

    Fast-growing and innovative Biotechnology Company is seeking a CSV Engineer specialized in QMS to join their dynamic team This is a direct hire opportunity, allowing for hybrid work model. Must be able to go into the office at least twice per week

    Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

    Responsibilities:

    • Supports cGMP qualification and ISO 9001:2015 certification efforts.
    • Assists in developing the computerized systems program.
    • Collaborates with stakeholders to deploy and implement computerized systems, including LMS, EDMS, ERP, and software development.
    • Maintains and improves computerized systems through procedure creation, review, and approval.
    • Manages computerized system applications through validation, maintenance, quality administration, training, and process improvement.
    • Executes documentation for CSA and CSV activities, including qualification and validation projects.
    • Performs failure analysis, risk assessments, and problem-solving for system deficiencies and deviations.
    • Conducts internal and external audits for system compliance with regulatory frameworks.
    • Ensures compliance with relevant regulatory requirements such as GxP/GMP.
    • Develops templates for risk assessments, user requirements, validation plans, and reports.
    • Implements reporting tools for analysis, trending, and metrics.
    • Assists in SOP, training material, and work instruction development.
    • Acts as a liaison between QA and project teams to ensure regulatory compliance.
    • Leads validation remediation strategy development for GxP systems.
    • Manages, coaches, and trains project/internal resources as needed.
    • Maintains inspection readiness and supports audit and inspection activities.
    • Contributes to QMS initiatives as assigned.
    • Provides QA approvals as needed.
    • Takes on additional tasks and projects to meet business objectives.

    Requirements:

    • BA/BS with 7+ years of Pharma/Biotech Quality Management Systems (QMS).
    • Experience with software, computerized systems, and/or control system validation.
    • Experience with eQMS (EDMS, LMS, etc.). Experience with Veeva eQMS and CMMS is a strong plus.