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    Lead Mechanical Engineer - Indianapolis, United States - i-Pharm Consulting

    i-Pharm Consulting
    i-Pharm Consulting Indianapolis, United States

    1 week ago

    Default job background
    Description

    Lead Mechanical Engineer - Lyophilizers

    Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years. You will be responsible for executing equipment improvement and capital projects in a cGMP setting associated with sterile injectable products.

    This opportunity will see you be the system owner for filling and Lyophilizer equipment.

    JOB TITLE

    Lead Mechanical Engineer / LME

    LOCATION

    USA / Indianapolis / Indiana / In

    SALARY

    $125K - $150k + Bonus

    ROLE/DESCRIPTION

    • You will provide technical support for the manufacturing equipment; investigations, continuous process improvements, change controls, and client onboarding.
    • Provide engineering leadership for technical projects; equipment specification and procurement, process development, drawing development, protocol development, validation input, and execution.
    • Interpret, modify and create engineering drawings; Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
    • Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.
    • Lead and provide technical support for technical investigations.

    REQUIREMENTS

    • Degree in Engineering related field
    • Minimum 10 years' experience in GMP
    • In-depth knowledge of aseptic manufacturing processes
    • Significant experience working with Lyophilizers and fill lines
    • Recent experience working on large scale pharma projects

    ABOUT i-PHARM CONSULTING

    i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics.

    TO APPLY

    If you would like to discuss this vacancy further, please call Principal Recruitment Consultant David Fearnley on , or email - If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

    KEY WORDS

    Lead Mechanical Engineer / Aseptic / Quality Engineering / QA Engineer / USA / GMP / Quality / ISO 9001 / Manufacturing / Calibration / Production / Lyophilizers / Fill Line / Engineer / Layouts / Isometrics / Building / Technical / Projects / Processes / change controls

    Desired Skills and Experience

    Degree in Engineering related field
    Minimum 10 years' experience in GMP
    In-depth knowledge of aseptic manufacturing processes
    Significant experience working with Lyophilizers and fill lines
    Recent experience working on large scale Pharma projects
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