Process Engineer I

DCI Donor Services (DDS) is looking for a dynamic and enthusiastic team member to join us to save lives!! Our mission at DCIDS is to save lives through organ and tissue donation, and we want professionals on our team that will embrace this important work!! DCI Donor Services is seeking a Process 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 support manufacturing and operational processes through process monitoring, data analysis, troubleshooting, and continuous improvement initiatives within our facility. You will work in cross-functional teams to support projects and to provide data to support business cases and long-term strategies. COMPANY OVERVIEW AND MISSION For over four decades, DCI Donor Services has been a leader in working to end the transplant waiting list. Our unique approach to service allows for nationwide donation, transplantation, and distribution of organs and tissues while maintaining close ties to our local communities. DCI Donor Services operates multiple organ procurement/tissue recovery organizations: Sierra Donor Services – New Mexico, Sierra Donor Services - California, and Tennessee Donor Services. We also maximize the gift of life through the DCI Donor Services Tissue Bank and Sierra Donor Services Eye Bank. Our performance is measured by the way we serve donor families and recipients. To be successful in this endeavor is our ultimate mission. By mobilizing the power of people and the potential of technology, we are honored to extend the reach of each donor’s gift and share the importance of the gift of life. With the help of our employee-led strategy team, we will ensure that all communities feel welcome and safe with us because we are a model for fairness, belonging, and forward thinking. Key responsibilities this position will perform include: 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 Support process validation and equipment qualification activities. Support process scale-up, technology transfer, and manufacturing readiness activities. Analyze process data to identify trends and opportunities for process improvement. Participate in root cause investigations and implementation of corrective actions. Develop process metrics and dashboards to monitor manufacturing performance. Assist with capacity planning and efficiency improvement initiatives. Support project activities and complete assigned deliverables to help ensure timely completion. Support investigations, deviations, CAPAs, and change controls related to manufacturing processes. Support manufacturing floor activities and provide day-to-day process engineering support. 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 Detail the job responsibilities in each step below The ideal candidate will have: Bachelor’s Degree in Biomedical, Mechanical, Chemical Engineering, or related degree. Master’s degree preferred 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…

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