Process Engineer

GSK•Rockville, MD

23h

About The Position

The Process Engineer’s function at the Rockville Biopharm site is to provide technical engineering and project management services for cGMP manufacturing operations including capital project management, equipment optimization and tech transfer support. Motivated engineering professional who can manage small to medium projects while supporting manufacturing operations . This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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. Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development. Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies. 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).

Requirements

BS in Engineering or related technical discipline such as Biological, Chemical, Mechanical.
2+ years of experience working in a regulated cGMP biopharmaceutical environment.

Nice To Haves

Experience with technical risk assessments and product control strategies.
Capable of working in a collaborative and team focused environment.
Demonstrated understanding of the product development process.
Able to evaluate potential innovative technology areas relevant to products.
Experience supporting batch and continuous industrial control systems.
Change control and deviation management experience.
Must be proficient with common business enterprise technologies including MS Office.
Working knowledge of biopharmaceutical production, quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes.
Demonstrated ability to participate as a member of a cross-functional team.
Basic understanding and knowledge of biopharmaceutical production equipment including but not limited to bioreactors, centrifuges, CIP skids, chromatography systems and filtration skids.
Project management experience, including the ability to manage a project by delivering scope, cost and schedule.

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.
Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development.
Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies.
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).