What are the responsibilities and job description for the Senior Project Engineer position at Formulated Solutions?
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 :
COMPUTER SKILLS :
Technical Skills and Experience (if applicable) :
Education and / or Training
Bachelor’s degree in chemical, Electrical, or Mechanical Engineering or related field.
PHYSICAL DEMANDS
