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    Senior Equipment Validation Engineer - New Jersey, United States - RBW Consulting

    RBW Consulting
    RBW Consulting New Jersey, United States

    2 weeks ago

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    Description

    RBW Consulting are excited to present an opportunity for a Senior Validation Engineer with a CDMO partner of ours

    With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products, with a particular focus on Injectables.

    Dedicated to quality and growth, our partner continually seeks to improve, over the past 5 years they have invested over $100M into their facilities to improve capabilities and expand capacity. Allowing you to work on large-scale projects and expand your own experience in a complex area.

    Responsibilities

    • Technical Expertise: Provide in-depth technical knowledge related to equipment qualification, requalification, and sterilization processes.
    • Validation Protocols and Reports: Develop and review validation protocols and reports for process equipment, critical utility systems, and environmental chambers during initial qualification and requalification.
    • Document Preparation and Review: Assist in preparing and reviewing technical documents, including change controls, regulatory submissions, deviation investigations, validation protocols, summary reports, processing records, procedures, VMPs, and APRs.
    • Aseptic Pharmaceutical Environment: Execute validation activities within an aseptic pharmaceutical environment.
    • Regulatory Compliance: Ensure compliance with FDA, ISO, EMA, and other applicable domestic and international regulations.
    • Technical Support: Provide technical support for start-up activities related to temperature mapping and sterilization programs.
    • Requalification Activities: Support periodic requalification activities for production equipment and systems.
    • Root Cause Investigations: Lead or assist in root cause investigations related to sterilization and other relevant activities.
    • Data Analysis: Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvement.
    • Cross-Functional Collaboration: Coordinate with cross-functional process teams to implement projects aimed at enhancing productivity, quality, and continuous improvement of sterilization processes.
    • Audits and Inspections: Participate in equipment sterilization programs during internal and external audits, including regulatory inspections.
    • Issue Resolution: Provide technical assistance for investigations into process/product issues, supporting validation deviations, and reviewing design requirements for products and equipment.
    • Customer Interaction: Interface with customers during transfer discussions, project timelines, and deliverables.
    • Safety Culture: Promote a safe working environment by adhering to safety rules and actively participating in safety-related activities.

    Requirements

    • 3+ years experience in Validation, including but not limited to Equipment and Sterilization
    • Bachelors or master's degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree
    • Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH

    If you could be interested in developing your career with a forward-thinking CDMO, please apply or reach out to me directly to organise a call.

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