What are the responsibilities and job description for the Senior Process Development Engineer position at The Steely Group?
This position is for an engineer / scientist focused on pharmaceutical / biologics manufacturing located in Minnesota. This position will support process development and early clinical manufacturing. The ideal candidate will have strong technical skills, strong written and verbal communication skills, and the ability to work independently and as a member of a team, and proven leadership experience. This is a hands-on role to support both current and future development and manufacturing of cutting-edge biopharmaceutical products.
Job Responsibilities :
Forward thinking / technical operations including :
- Lead for process and equipment validation activities for GMP manufacturing PPQ / pre-commercial activities.
- Support process and new product development activities and transfer to the manufacturing area.
- Collaborate with scientists to plan and execute experiments and evaluate data.
- Generate reports to support manufacturing changes in a regulatory compliant manner.
- Troubleshoot manufacturing processes and propose solutions.
- Identify opportunities to improve process efficiency and work with the development team to determine the best plan of actions for implementation.
- Develop expertise in specific areas of manufacturing (SME).
- Champion safety in all operations.
- Work with technical drawings, spec sheets, and requirements to complete tasks.
- Construct and perform DOE studies and use CpK / PpK analysis to track process success.
- Tech transfer of new and updated processes to CMOs including training of operators to new processes.
- Executing batches following cGMP and GDP principles (as needed).
- Writing and reviewing documents including necessary FDA compliant work instructions / batch records / forms / SOPs.
- Routinely participating in new procedure planning and implementation into the manufacturing area.
- Assist with performing routine maintenance of production equipment and production suites.
- Deviation identification, support investigations and CAPA support.
Basic Requirements :
Preferred requirements :
