Process Engineer I

About the Role

DCI Donor Services (DDS) is seeking a Process Engineer I to join its Research and Development team in Nashville, TN. This role supports manufacturing and operational processes through monitoring, data analysis, troubleshooting, and continuous improvement. The position involves working in cross-functional teams to support projects and provide data for business cases and long-term strategies.

Key Responsibilities

• Assist in the creation of engineering and validation protocols for new products/processes.
• Assist in the development of SOPs 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 the 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.
• 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory.
• Act as a role model by supporting and exhibiting DCIDS core values: selfless, hardworking, passionate, and dependable.
• Perform other related duties as assigned.

Requirements & Tech Stack

• Bachelor’s Degree in Biomedical, Mechanical, or Chemical Engineering, or a related degree.
• Master’s degree preferred.
• 0 – 2 years of experience in biotech research, process engineering, or product development.
• 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 is preferred.
• LEAN/Six Sigma certification preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, etc.).
• Experience with SolidWorks (or equivalent CAD software).
• Familiarity with computer software programs relevant to the engineering discipline and project management.