Project Engineer
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- Identify process related operational excellence opportunities and lead process improvement initiatives from the laboratory into manufacturing or supporting processes
- Support execution of data trending and statistical process analysis related to project engineering
- Support multiple projects simultaneously. Ensure projects are completed within budget and on schedule
- Support technical direction for process related deviations, CAPAs and change controls
- Assist in creation of engineering and validation protocols for new products/processes
- Assist in development of SOP’s and Work Instructions for new formulations, products and product improvements
- Assist in sourcing, installing, and developing maintenance programs for manufacturing equipment
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Provide routine process monitoring and troubleshooting
- Represent R&D and collaborates with other functions such as Manufacturing, Quality, and Regulatory
- 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
- 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:
Education Required:
Bachelor’s degree in Biomedical, Mechanical, Chemical Engineering or related degree.
Experience:
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.
Licenses/
Certifications:
Lean Six Sigma certification preferred.
Computer Skills:
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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