Process Engineer Ii Jobs

Position Summary & Role

The Manufacturing Science and Technology (MSAT) team is responsible for leading the introduction of new manufacturing processes to facility clinical and commercial manufacturing. This includes performing technology transfer from the development laboratory into all phases of GMP manufacturing and defining relevant operational/technical standards and practices for the site. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.

The Process Engineer will work in the MSAT group to provide technical support to operations at the Philadelphia, PA site, for both vector and cell and gene therapy production. This position will have a focus on the digital systems used in Manufacturing, supporting the transition from Process Development during technology transfer. This role will represent Manufacturing while working with Quality and Digital to implement the automation strategy for the Manufacturing Execution System (MES) and other system integrations to MES. The process Engineering will facilitate initial build of new workflows, as well as support change, continuous improvement, validation, operation, and maintenance of the site’s MES. As the MES subject matter expert, this Process Engineer will help clients better understand the system capabilities and development requirements, providing regular updates to ensure that project deliverables are being met according to schedule. This role will also facilitate electronic batch records (EBR) report development, determining client requirements and conveying what the system is capable of generating. The Process Engineer will collaborate with peers across departments to ensure completion of projects.

Job Responsibilities

MSAT Team Member

Technology Transfer to GMP Production

MES Lead

Minimum Qualifications:

Preferred Qualifications