Senior Process Development Engineer

2 months ago

Rochester, United States Rion Full time

This position is for an engineer/scientist focused on pharmaceutical/biologics manufacturing located in Rochester, MN. 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. This is a hands-on role to support both current and future development and manufacturing of cutting-edge biopharmaceutical products.

This position requires the individual to be onsite every day, located in or near Rochester, MN.


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 Qualifications:


·       Bachelor’s degree in a science or engineering discipline or equivalent level of proven technical experience.

·       8 years of process development experience in BioPharma Industry.

·       Detail oriented and self-motivated with strong written and verbal communication skills.

·       Ability to work independently/autonomously, within prescribed guidelines, and as a team member.

·       Demonstrated ability to follow detailed directions in a manufacturing GMP environment or equivalent.


Preferred Qualifications:


·       Master’s degree or higher in science or engineering

·       10+ years of experience in a manufacturing/process development environment.

·       LEAN, Six-Sigma, or other efficiency program experience

·       Experience manufacturing in a pharmaceutical environment.

·       Experience leading a team. Direct supervisor experience a plus.

·       Experience with pharmaceutical product purification and single use systems.

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