Job Description

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 includes 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, SOPs 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.

PHYSICAL DEMANDS

• 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.

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