• Principal Mfg Engineer

    Job Locations US-FL-Miami
    Job ID
    2018-1317
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Engineering-All Disciplines
    FLSA Status
    Exempt
    Work Shift
    1st Shift
  • Overview

    The Principal MTS Engineer will oversee the IQ/OQ/PQ processes including qualification project management, procedural guidance, equipment engineering studies, drafting and executing protocols, and report writing. This position will be the technical lead for qualification at Noven Pharmaceuticals and provide insight into the latest statistical and efficiency techniques for equipment and process qualification. The position responsibility includes cross functional collaboration in the equipment design phase including URS, FAT, and SAT, and the design, execution, and summarization of IQ/OQ/PQ protocols. This position will understand the products and processes at Noven Pharmaceuticals and understand equipment impact on products. The position will interact mainly with the Engineering and Quality Engineering departments, as well as, process engineers in the MTS department bringing equipment design and operational expertise.

    Responsibilities

    • Cross functional collaboration in equipment design phase.
    • Champion equipment design and functionality for product performance.
    • Define efficient procedures for qualification that ensure on-time completion of projects.
    • Draft, execute, and summarize qualification protocols and reports.
    • Experience in statistical qualification criteria a plus.
    • Must be able to analyze data and assess product and process performance.
    • Manage all qualification projects to ensure effective and efficient results.
    • Promote “team” atmosphere between all functional departments.

    Qualifications

    • Experience in GMP manufacturing of pharmaceutical, biotechnology, or medical device products.
    • Detail oriented with strong statistical qualification experience.
    • Broad technical ability including mechanical, biomedical, or chemical engineering skill sets or experience or strong experience in equipment mechanical design, process / product understanding, and qualification.
    • Ability to quickly learn interactions of product ingredients with mechanical processes.
    • Strong initiative to learn, challenge existing states when appropriate, initiate projects of improvement, and communicate across departments facilitating resolution of equipment design or product impact issues.   
    • Ability to summarize complex data into clear and conclusive results.
    • Passion for pharmaceutical development and market supply through commercialization.
    • Self-expectation to establish a new standard of excellence for the position and department.
    • Resolve to push back on equipment design projects that do not meet the requirements for effective manufacturing.
    • A bias for action taking initiative to complete equipment qualifications on time.
    • Ability to interact with all levels of the business (senior leaders to working teams).
    • Ability to influence decision makers with clear presentations of data and recommended solutions.

     

    Education & Experience:

    Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor’s degree in other Engineering or Science discipline with relevant equipment understanding. Candidate will possess proven track record of successful equipment qualification including effective and on-time applications. 8-12 years or more, professional experience in a regulated environment. Knowledge of transdermal pharmaceuticals and manufacturing a plus. Experience in project or team management. Excellent written and verbal communication skills; able to establish and maintain professional relationships. Keen attention to detail. Experience with domestic (FDA) and/or international health authorities' (MCA, IMB, JP, EU, etc) regulations, GMP, and ISO guidelines desired.

     

    Work Environment:

    Air-conditioned office or manufacturing facility environment.  Roughly 70% sitting at desk, 30%  standing / sitting in a manufacturing environment. Priorities often shifting, with frequent interruptions and tight deadlines; extra hours occasionally required.

     

    Physical Demands:

    Occasionally required to stand for more than two hours at a time.  Occasionally lift and carry objects weighing up to twenty pounds.  Visual acuity and manual dexterity required to perform experiments, operate computer and proofread documents.

     



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