Biotechnology Process Engineer
5 days ago
DCI Donor Services is a leading organization in the biotechnology industry, leveraging tissue donation to develop life-changing solutions for patients.
About the RoleWe are seeking an experienced Project Engineer I to join our Research and Development team at our Nashville, TN site.
Responsibilities- Identify operational excellence opportunities and lead process improvement initiatives from laboratory to manufacturing or supporting processes.
- Support data trending and statistical process analysis related to project engineering.
- Manage multiple projects simultaneously, ensuring timely completion within budget and schedule.
- Provide technical direction for process-related deviations, CAPAs, and change controls.
- Develop engineering and validation protocols for new products/processes.
- Collaborate on the creation of SOPs and Work Instructions for new formulations, products, and product improvements.
- Sources, installs, and develops maintenance programs for manufacturing equipment.
- Support scale-up, transfer of process technology, and clinical/commercial manufacturing operations.
- Perform routine process monitoring and troubleshooting.
- Represent R&D and collaborate with other functions such as Manufacturing, Quality, and Regulatory.
- Adhere to DCIDS core values: selfless, hardworking, passionate, and dependable.
• Bachelor's degree in Biomedical, Mechanical, Chemical Engineering, or related field.
• 0-2 years of biotech research, process engineering, or product development experience.
• Direct experience with regulated environments (FDA, OSHA, EPA) and/or cGMP procedures and engineering practices preferred.
• Lean Six Sigma certification desired.
• Proficiency in Microsoft Office Suite, SolidWorks, and relevant engineering software.
CompensationThe estimated salary for this position ranges from $65,000 to $85,000 per year, depending on qualifications and experience.
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