Project Engineer, Quality Engineering

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Regular Full-Time Largo, FL, US

30+ days ago Requisition

Completes engineering projects of small scope under the direction of senior engineers by organizing and controlling project elements. Support larger projects through detailed design and execution of smaller project deliverables.

• Determine project specifications by defining the user requirements.
• Develop preliminary project scope and order of magnitude estimate.
• Present business case and obtain capital funding through capital request procedure.
• Develop final detailed scope and parameters for project design and implementation.
• Develop project schedule and delineate project responsibilities
• Complete detailed design including CAD layouts, 3D modeling using Solid Works, and instrumentation specifications
• Develop Design Specification/ Design Qualification Documents
• Construction management including defining constraints, procedures, data collection methods, and performance standards within boundaries of corporate policy
• Prepare scheduled and necessary updates of construction activities and analysis of manpower and equipment required
• Create and Execute Factory Acceptance Testing and Site Commissioning Documents (as applicable)
• Create and administer appropriate metrics to monitor project performance
• Inform all supervisors and subcontractors promptly of any construction schedule changes, and work closely with all stakeholders to ensure requirements are met
• Maintain budgetary, scheduling, and project database oversight, and report regularly to engineering leadership to keep him/her constantly informed of job progress, plans and problems that could significantly affect costs or schedules
• Manage compliance, quality control, and quality assurance standards and specifications

• Required
• Bachelor’s degree in engineering or related field of study.
• Strong field management experience
• Must be able to lift to 20 pounds on a regular basis.
• Preferred Additional
  • Background in or working knowledge of pharmaceutical industry and cGMP’s preferable
  • 0–5 years’ experience in Chemical Manufacturing and/ or consumer healthcare packaging

• Strong working knowledge of design software, including AutoCAD or equivalent.
• Proven understanding of compliance and quality assurance guidelines and best practices

• Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator
• PowerPoint, Word, Excel, and a basic understanding of Microsoft media applications is required.

• Technical skills appropriate for execution of technical transfers of topical products
• Data analysis with a good understanding of statistical process control
• PAT experience is preferred

• Bachelor’s degree in engineering or related field.

• Must be able to lift and maneuver 40 pounds.
• Must be capable of standing for extended periods of time.
• Must be able to wear personal protection equipment, which includes gloves and a respirator, when required.