Process Engineer

Samsung Biologics; Rockville (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision benefits on

Job summary

Samsung Biologics in Rockville, MD is seeking a Process Engineer to provide engineering and project management support for cGMP manufacturing operations. The role covers capital project management, equipment optimization and tech transfer activities to enable scalable production.

The candidate will lead SME activities for biopharmaceutical processing equipment, coordinate internal and external resources, and ensure CAPA and change control processes are followed in a regulated environment.

Qualifications

• Experience in biopharmaceutical, biotechnology, or regulated manufacturing environments.
• Knowledge of upstream and/or downstream process equipment and utility systems.
• Experience managing capital projects and equipment qualification, commissioning, and validation.

Responsibilities

• Provide engineering support for design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale.
• Manage capital projects and engineer solutions involving retrofits and equipment acquisition.
• Support technology transfer and scale-up activities.
• Lead resolution of technical issues with manufacturing operations and equipment.
• Collaborates with Validation, Automation, Quality, Metrology, Maintenance and Process Development.
• Apply knowledge of process and utility systems to improve manufacturing efficiencies.
• Experience with project management including schedule, cost, and communications.

Skills

Process engineering

Project management

Technology transfer

Equipment optimization

Education

BS in Engineering

Job description

The Process Engineer’s function at the Rockville Biopharmaceutical 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.

KEY 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)

Experience:

• Experience supporting biopharmaceutical, biotechnology, pharmaceutical, or other regulated manufacturing environments.

• Knowledge of upstream and/or downstream process equipment and associated utility systems.

• Experience managing capital projects and supporting equipment qualification, commissioning, and validation activities.

• Familiarity with cGMP regulations, change control, deviation investigations, root cause analysis, and CAPA processes.

Education

• BS in Engineering or equivalent degree

The anticipated salary range for this position in Maryland is $89,925 to $119,900plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

Benefits:

13 paid holidays

Vacation time

401K match

Medical, dental and vision benefit effective day one of employment