SENIOR PROJECT ENGINEER

Company: Formulated Solutions
Location: Cleveland
Posted on: November 15, 2024

Job Description:

PRIMARY PURPOSE:

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

MAJOR DUTIES AND RESPONSIBILITIES INCLUDE:

• Determine project specifications by defining the user requirements including manufacturing equipment purchase/upgrades and/or change parts requirements.
• Work with equipment and outside vendors to define user requirements and develop quotes.
• Collaborate with other departments including Procurement, SHE, Operations, Maintenance, Quality Control to ensure cross functional agreement during project execution.
• 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 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.
• Development management of change document as required
• Prepare scheduled and necessary updates of construction activities and analysis of manpower and equipment required.
• Create and Execute Factory Acceptance Testing, Site Commissioning Documents and Installation/Operational Qualification 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 project manager 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.
• Participate in deviation investigations, problem solving activities, and continuous improvement activities as required.
• Write Work Instructions, NOE's, Risk Assessments, Deviations, SOP's as needed. QUALIFICATION:
  
  Required
  
• Bachelor's degree in Chemical, Electrical, or Mechanical Engineering or related field of study.
• Strong field management experience
• Project engineering experience
• Must be able to lift 20 pounds on a regular basis
• 5 -7 years experience in consumer OTC/healthcare packaging or related industry Preferred Additional
• Background in or working knowledge of pharmaceutical industry and cGMP's preferable.
  
  CRITICAL SKILLS AND ABILITIES:
  • Strong working knowledge of design software, including AutoCAD
  • Proven understanding of compliance and quality assurance guidelines and best practices COMPUTER SKILLS:
    • Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator.
    • Power Point, Word, Excel, and a basic understanding of Microsoft media applications is required. Technical Skills and Experience (if applicable):
      • Technical skills appropriate for execution of technical transfers of topical products
      • Data analysis with a good understanding of statistical process control Education and/or Training
        • Bachelor's degree in Chemical, Electrical, or Mechanical Engineering or related field.

Keywords: Formulated Solutions, Alpharetta , SENIOR PROJECT ENGINEER, Engineering , Cleveland, Georgia