• Mfg Engineer IV

    Job Locations US-FL-Miami
    Job ID
    2018-1291
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Engineering-All Disciplines
    FLSA Status
    Exempt
    Work Shift
    1st Shift
  • Overview

    Responsible for the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through the pilot plant and manufacturing scale.  Provides expertise engineering, design and process and/or scale-up.  Assists manufacturing operation in problem solving with regards to materials, components, equipment and systems.  Develops and recommends new process formulas and technologies to achieve cost effectiveness and improved product quality.  Recommends processes for pouching machines and packaging systems.  These pharmaceutical converting systems require automation experience with both PLC and SCADA software systems that control both intermittent or continuous motion line machines.

    Establishes operating equipment specifications and improves manufacturing techniques.  Involved in new product scale-up, process optimization, technology transfer, design of experiments, as well as process validation activities.  Interfaces with appropriate departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. May lead team of junior engineers and technicians.

    Responsibilities

    • Applies knowledge of engineering principles and practices in broad areas of assignments and related fields.
    • Makes decisions independently on engineering problems and methods, and represents the organization in meetings, collaborations, conferences to resolve important questions and to plan and coordinate work.
    • Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines. Knowledge of materials, their chemical/structural properties, and material handling helpful.
    • Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters.
    • Consults with supervisor concerning unusual problems and developments.
    • Responsible for one or more of the following:
      • In a supervisory capacity, plans, develops, coordinates, and directs large critical engineering projects and/or a number of small projects with many complex features. Design specialized equipment for use in specific areas.
      • As an individual researcher, carries out complex or novel assignments requiring the development of new or improved techniques or procedures. Provide technical support for process development.
      • Work is expected to result in the development of new or improved techniques or procedures.
      • Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.
      • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
    • Performs as a staff consultant on a technical specialty, a type of facility or equipment, or a program function.
    • May technically supervise, coordinate and review the work of a small staff of engineers and technicians, estimates manpower needs and schedules and assigns work to meet completion date, or, as individual researcher or staff specialist may be assisted on projects by other engineers or technicians.
    • Practices company safety and quality policies and procedures. Actively adheres to and require conformance to the same.
    • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
    • Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company and or outside entities. Select and monitor outside vendors, contractors; negotiate fabrication contracts
    • Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Supervise the installation, modification and field service of new and existing equipment.
    • Ensure equipment related information such as trends, issues, availability, performance, and quality (OEE) associated with machine maintenance, calibration and spare parts requirements is properly analyzed and then passed onto the production, maintenance and calibration organizations.

    Qualifications

    Competencies:

     

    Education / Experience:

    BS or equivalent in Electrical, Industrial Engineering or a related engineering discipline with 5 – 9 years of experience and/or training; or MS with 3 – 7 years of experience and/or training or equivalent combination of education and experience.  Experience in the pharmaceutical or medical device industries will be an asset.  Must possess the basic understanding of engineering fundamentals, engineering best practices, troubleshooting methodology as well as strong familiarity of the scientific method. 

                   

    Good written and oral English communication skills. Computer literate a must, strength with Statistics used for Design of Experiments as well as MS Project and Excel required.  OEE Overall Equipment Efficiency, Lean Sigma, TQM, Project Management and Controls experience a plus for executing smaller tasks, large projects and initiatives.  Experience with Business and Technical systems such as TrackWise, Master Controls, JDE, Minitab, AutoCAD and AutoDesk Vault a plus.

     

     

    Judgment / Decision Making:

    Works on complex problems of diverse scope where analysis of data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

     

     

    Work Environment:

    Office, Utility Yard, Plant floor, Plant Floor Support Areas, Active pharmaceutical products

     

     

    Physical Demands:         

    The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and smell.  The employee must be able to sit or stand for several hours, as well as lift and/or move up to 100 pounds.

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