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: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 DocumentsConstruction management includes 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 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.
QUALIFICATION:A.
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.
B.
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
CRITICAL SKILLS AND ABILITIES:Strong working knowledge of design software, including AutoCAD and CAD/CAM Circuit DesignProven 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 productsData analysis with a good understanding of statistical process controlPAT experience is preferred
Education and/or Training· Bachelor's degree in engineering or related field.
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