R&D Engineer I

DCI Donor Services, Inc.; Nashville, Northern (TN, KY); Hybrid; USD 65,000 - 80,000; Full time

Benefits offered by this job

Up to 184 hours PTO first year

Up to 72 hours Sick Time first year

Medical plans

Dental and Vision coverage

403(b) with matching

Life insurance and AD&D

Long-term disability insurance

Wellness program

Supplemental insurance

Discounts on home/auto/renter/pet

Cell phone discounts

Job summary

DCI Donor Services, Inc. in Nashville, TN seeks a Regular Full-Time Professional to advance process engineering efforts across R&D and manufacturing.

You will identify improvements, support data analysis, and help ensure projects finish on time and within budget. Ideal candidates have a biomedical, mechanical, or chemical engineering background with 0–2 years in biotech or regulated environments and familiarity with cGMP, CAD software, and MS Office.

Qualifications

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

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 R&D 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 creating 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

Skills

Process improvement

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor’s Degree in Biomedical/Mechanical/Chemical Engineering

Master’s degree preferred

Experience in regulated environments (FDA/OSHA/EPA)

Tools

SolidWorks

CAD software

MS Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regular Full-Time Professional Nashville, TN, US

7 days ago Requisition ID: 2677

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 three organ procurement/tissue recovery organizations: Sierra Donor Services California and New Mexico, 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:

• 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 R&D 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 creating 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

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

We offer a competitive compensation package including:

• Up to 184 hours of PTO your first year
• Up to 72 hours of Sick Time your first year
• Two Medical Plans (your choice of a PPO or HDHP), Dental, and Vision Coverage
• 403(b) plan with matching contribution
• Company provided term life, AD&D, and long-term disability insurance
• Wellness Program
• Supplemental insurance benefits such as accident coverage and short-term disability
• Discounts on home/auto/renter/pet insurance
• Cell phone discounts through Verizon

DCIDS is an EOE/AA employer – M/F/Vet/Disability.