Process Engineer

Samsung Biologics•Rockville, MD

About The Position

The Process Engineer will provide engineering support for the design, testing, and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale. This includes stainless steel and single-use bioreactors, centrifuges, chromatography systems, filtration skids, and pasteurizers. The role involves managing capital projects, engineering solutions for retrofits, modifications, and equipment acquisition, and supporting technology transfer and scale-up activities. The engineer will lead the resolution of technical issues with manufacturing operations and equipment, collaborating with various support groups such as Validation, Automation, Quality, Metrology, and Maintenance. A key aspect of the role is applying knowledge of process and utility systems to recommend improvements for manufacturing systems, equipment, and process efficiencies. Experience in project management, including schedule, cost, and communication, as well as coordinating resources, is essential. The position requires acting as a subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment, assisting in design, procurement, testing (FAT, SAT, commissioning), installation, and validation. The ability to negotiate contracts, bids, and change orders with vendors or contractors is also necessary. Additionally, the role involves supporting investigations and recommending solutions with stakeholders to achieve consensus on corrective and preventive actions (CAPA).

Requirements

Experience with project management (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities.
Capable of negotiating contracts, bids, and change orders with vendors or contractors.
Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA).

Responsibilities

Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale including stainless and single-use bioreactors, centrifuges, chromatography systems, filtration skids, pasteurizers, chromatography skids, etc.
Manage capital projects and engineer solutions involving retrofits, modifications and acquisition of process equipment.
Support execution of technology transfer and scale-up activities.
Lead resolution of technical issues with manufacturing operations and equipment.
Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development.
Apply knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies.
Manage projects including schedule, cost, communications and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
Act as a subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities.
Negotiate contracts, bids, and change orders with vendors or contractors.
Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA).