Job Description

DCI Donor Services is seeking a Project Engineer I to join our Research and Development team at the Nashville, TN site. This is an exciting opportunity for an individual looking to make an impact in the biotechnology industry by helping leverage tissue donation to develop life-changing solutions for patients. In this role, you will provide technical expertise and leadership to projects primarily supporting new product development and manufacturing activities within our facility. You will work in cross-functional teams to support projects and to provide data to support business cases and long-term strategy.

MAJOR DUTIES AND RESPONSIBILITIES

1. Identify process related operational excellence opportunities and lead process improvement initiatives from the laboratory into manufacturing or supporting processes
2. Support execution of data trending and statistical process analysis related to project engineering
3. Support multiple projects simultaneously. Ensure projects are completed within budget and on schedule
4. Support technical direction for process related deviations, CAPAs and change controls
5. Assist in creation of engineering and validation protocols for new products/processes
6. Assist in development of SOP’s and Work Instructions for new formulations, products and product improvements
7. Assist in sourcing, installing, and developing maintenance programs for manufacturing equipment
8. Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
9. Provide routine process monitoring and troubleshooting
10. Represent R&D and collaborates with other functions such as Manufacturing, Quality, and Regulatory
11. Act as a role model for DCIDS by supporting, reinforcing, and exhibiting behaviors consistent with the DCIDS core values, which are: selfless, hardworking, passionate, and dependable
12. Perform other related duties as assigned

PHYSICAL TRAITS : Sitting, standing, and walking: communicates in verbal and written form. Bending and stooping. Computer keying. Heavy lifting up to 70 pounds.

QUALIFICATIONS:

Bachelor’s degree in Biomedical, Mechanical, Chemical Engineering or related degree.

0 – 2 years of biotech research, process engineering or product development experience. Direct experience with regulated environments (FDA, OSHA, EPA, etc.) and/or with cGMP procedures and engineering practices on tissue banking / pharmaceutical /biotech production processes, clean utilities, facilities, instruments, and equipment preferred.

Lean Six Sigma certification preferred.

Microsoft Office Suite (Word, Excel, etc.), SolidWorks (or equivalent CAD software) and computer software programs relevant to the engineering discipline and project management.

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