Project Engineer III

Thorne•Summerville, SC

15h•Onsite

About The Position

The Project Engineer III ensures that all necessary components, tasks, and resources are capable of meeting established quality standards and goals. This position supports department operations to ensure compliance with cGMP and OSHA regulations, company Standard Operating Procedures (SOPs) as well as meeting production goals. Duties and responsibilities are commensurate with the experience level of the Project Engineer and by assignment from Engineering Manager. Project Engineer III will be required to manage small to large cross functional teams to take a design or project from initial concept to a fully functional production machine, system, or process.

Requirements

Bachelor’s degree in Mechanical Engineering, with documented combination of education and experience readily available.
A minimum of 5-7 years’ hands-on experience in Project Engineering, Manufacturing Engineering, or another relevant field in an FDA-regulated environment is preferred.
Ability to acquire the necessary knowledge in all areas of manufacturing, including: Mixing, High Speed Encapsulation, Low Speed Encapsulation, Bottling (capsule and powder), Labeling, production components, raw materials and product powders.
Ability to work in / manage cross functional teams for multiple projects of various complexities and priorities.
Ability to evaluate the proper balance of quality, cost, and production output to make solution and goal-oriented decisions yet be able to distinguish high risk decisions that should be taken to the proper level of management when the risks to quality, cost and production are significant.
Develop and deliver on assigned objectives within requested timeframes.
Build, develop, motivate, and engage high performing teams and work cross-functionally.

Nice To Haves

Experience in Plant Expansion, Automation, High Speed Packaging Lines, or similar projects is a plus.

Responsibilities

Develop business case, lead, and execute assigned Engineering projects.
Develop detailed project schedules and communicate project progress to leadership.
Collaborate with different departments at Thorne to ensure timely completion of project tasks.
Create detailed equipment specifications working with Engineering, Maintenance and Suppliers/Vendors.
Create detailed Request for Quote (RFQ) documents for large complex projects.
Generate detailed plant layouts for production lines in AutoCAD and build consensus with Operations.
Lead and manage equipment installations including utilities, start-up testing and commissioning.
Work with Controls Group to generate detailed strategies for Process Monitoring & Controls.
Collaborate with Validations Group to plan and help execute equipment validations such as IQ/OQ/PQ.
Create detailed specifications and execute Factory and Site Acceptance Testing (FAT, SAT) including any offsite travel in support of the qualification processes.
Generate solid models and detailed drawings for custom parts, spare parts, tooling as part of projects.
Provide guidance, develop, and mentor junior engineers as well as function as delegate for Engineering Manager.
Research and maintain knowledge of new manufacturing technologies as applicable to Thorne and provide executable recommendations to leadership.
Calculate project costs in details and compile budget for planning and justification purposes.
Support continuous improvement projects if assigned.
Perform machinery troubleshooting if designated as Subject Matter Expert (SME).
Complete SOP / Change Control generation & review.
Coordinate with Production Department to improve productivity and efficiency.
Identify gaps in equipment capabilities and recommend alternatives.
Provide technical support and advice as required in response to process and equipment problems to other groups as requested by the Engineering Manager.
Evaluate data and provide reports to management on a variety of topics as requested.
Support general operations concerning AutoCAD and SolidWorks drawings as directed.
Coordinate with vendors concerning raw material problems and solutions as directed.
Perform Corrective Action responses to various audit or production related problems as directed.