• Qualification Engineer

    Job Locations US-FL-Miami
    Job ID
    2018-1314
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Operations
    FLSA Status
    Exempt
    Work Shift
    1st Shift
  • Overview

    The Qualification Engineer will ensure all equipment used to manufacture products at Noven Pharmaceuticals meets its design requirements and is qualified for its intended purpose. This entails oversight of equipment design including URS, FAT, and SAT, and the design, execution, and summarization of equipment installation and operational qualification protocols. The position will interact mainly with the Engineering and Quality Engineering departments, as well as, process qualification resources.

    Responsibilities

    • Draft and execute protocols and complete qualification reports.
    • Communicate equipment design and functionality knowledge to MTS process engineers.
    • Apply statistical success criteria to equipment qualification.
    • Must be able to analyze data and assess equipment performance.
    • Manage individual qualification tasks to ensure proper achievement of results.
    • Promote “team” atmosphere between all functional departments.

     

    Qualifications

    Competencies:

    • Knowledge of and experience in equipment qualification desired.
    • Experience in GMP manufacturing of pharmaceutical products a plus.
    • Knowledge of and experience in mechanical equipment design and functionality.
    • Detail oriented with statistical experience.
    • Broad technical ability including mechanical or chemical engineering skill sets or experience.
    • 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 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. 2-4 years of 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 equal time spent sitting at desk or 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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