Process Engineer
On-siteRockville, Maryland, United States
Job Summary
Provide engineering support for the design, testing, and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale, including bioreactors, centrifuges, and chromatography systems. Manage capital projects involving retrofits, modifications, and acquisition of process equipment while supporting technology transfer and scale-up activities. Lead resolution of technical issues with manufacturing operations and collaborate with Validation, Automation, Quality, and Maintenance teams. Apply knowledge of process and utility systems to improve manufacturing efficiencies and act as a subject matter expert for Upstream and Downstream equipment. Execute design, procurement, testing, installation, and validation activities while negotiating contracts and bids with vendors. Support investigations to recommend solutions and gain consensus on corrective and preventive actions. Work within Samsung Biologics' integrated CDMO model to support biologics product development and manufacturing at every stage.
Required Qualifications
- Engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale
- Experience with stainless and single-use bioreactors
- Experience with centrifuges
- Experience with chromatography systems
- Experience with filtration skids
- Experience with pasteurizers
- Experience with chromatography skids
- Manage capital projects
- 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
- Experience with project management (schedule, cost, communications)
- Coordinate internal and external resources to execute projects in a timely and cost-effective manner
- Be Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment
- 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)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.