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Senior Project Engineer

3 months ago

Cleveland, United States Formulated Solutions Full time

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.


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

  1. Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related field of study.
  2. Strong field management experience
  3. Project engineering experience
  4. Must be able to lift 20 pounds on a regular basis
  5. 5 -7 years experience in consumer OTC/healthcare packaging or related industry

Preferred Additional

  1. 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.