Biologics Process Engineer

Team

Biologics

Minimum Requirements for Fulfilling Team Role

Education

• BS or MS in Chemical Engineering, Biochemical Engineering, Materials Engineering or other related engineering discipline

Experience

• With a BS, 5-8 years process development experience in a GMP medical
  device, pharmaceutical, or biological industry setting, 3-6 years with an MS

Other

• Excellent interpersonal skills to allow effective participation in project teams
• Self motivated person with initiative to complete tasks independently
• Excellent oral and written communication skills
• Experience with process development using principles of design for manufacturability in the medical device or drug delivery field
• Understanding and use of statistical methods in experiment design, data analysis and development of highly capable manufacturing processes
•  Excellent understanding of current Good Manufacturing Practices (cGMP)  and a knowledge of Quality System Regulations (QSR) is a plus
•  Prior experience in development of medical device or biological products is preferred
• Previous experience in development of instruments or accessories for minimally invasive surgical procedures is a big plus

Responsibilities Include But Are Not Limited To

1. Lead the process development effort to develop and scale-up the manufacturing process for medical device and combination products. This will involve working closely as a team with the product design, research and quality groups, starting at an early stage and using principles of concurrent engineering to ensure manufacturability of the design.
2. Design and develop processes for manufacturing medical devices (and combination products) for clinical trials  and commercial markets.
3. Assist in the evaluation and selection of contract manufacturing vendors.
4. Identify, generate specifications and qualify sources for materials and components. Work closely with the vendors to assure quality, low cost and on-time delivery. Develop strategy for alternate sourcing as appropriate.
5. Generate specifications and develop custom pilot scale and manufacturing equipment; develop and implement plans for IQ, OQ and PQ of the equipment.
6. Set-up a pilot scale manufacturing process for making clinical supplies under GMP conditions.
7. Work with in-house groups and vendors to ensure compliance of the process.
8. Work with the Quality group to generate documentation and develop a training program to support the manufacturing operation.
9. Plan, participate in and monitor manufacturing of clinical supplies.
10. Monitor the performance of processes and equipment and make recommendations for continuous improvement.
11. Conduct detailed analysis of each unit operation and make recommendations regarding in-house versus contract manufacturing.
12. Work with the in-house manufacturing group and/or contract manufacturing vendor to scale-up, validate and transfer the commercial manufacturing process.
13. Know, apply and contribute to improvement of Exactech Quality System in all responsibilities at Exactech.
14. Assist and support other employees, teams and sales personnel as necessary.
15. Other responsibilities of the Biologics Team, as necessary.

For more information, send e-mail to human.resources@exac.com.