CQV Automation Engineer - Washington - Stark Pharma

    Stark Pharma
    Stark Pharma Washington

    1 week ago

    Description

    Job Title: CQV Automation Engineer
    Location: United States (Remote)
    Experience: 10+ years
    Work Model: Remote (with limited onsite travel)
    Contract Type: Long-term contract (12 months+, extension likely)

    Role Overview


    We are seeking an experienced CQV Automation Engineer with deep hands‑on expertise in DeltaV systems. This role supports commissioning, qualification, and validation activities across instrumentation and control systems. The position is primarily remote, with an initial onsite requirement and periodic travel thereafter.

    Required Qualifications

    • 10+ years of experience in CQV processes and methodologies
    • Strong, hands‑on expertise with DeltaV DCS
    • Proven ability to develop CQV documentation independently
    • Deep understanding of IV, OV, and RV activities
    • Experience working in regulated environments (GMP preferred)
    • Strong analytical, problem‑solving, and communication skills
    • Ability to work independently with minimal supervision

    Key Responsibilities

    • Develop and execute CQV activities for DeltaV systems
    • Author detailed test scripts and validation documentation
    • Create documentation from scratch using provided templates
    • Write, review, and execute:
      • Installation Verification (IV)
      • Operational Verification (OV)
      • Requirements Verification (RV)
    • Ensure system functionality, integrity, and compliance
    • Focus on instrumentation, controls, and operational processes
    • Support commissioning and qualification of automated systems
    • Collaborate with engineering, quality, and operations teams
    • Identify and resolve issues during CQV execution
    • Maintain compliance with regulatory and quality standards throughout the CQV lifecycle

    Documentation & Compliance

    • Ensure accuracy, traceability, and completeness of all CQV deliverables
    • Follow established validation methodologies and regulatory expectations
    • Support audits and reviews as required

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