Biopharma Process Engineer - Capital Projects Lead

Samsung Biologics RKV; 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 coverage

Job summary

Samsung Biologics is seeking a Process Engineer at the Rockville site to provide technical engineering and project management for cGMP manufacturing, including capital projects, equipment optimization and tech transfer support. The role requires a BS in Engineering and hands-on coordination of design, testing, commissioning, and validation.

Experience with upstream/downstream equipment, CAPA, change control, and regulatory compliance is essential to drive process improvements and successful tech

Qualifications

• BS in Engineering or equivalent degree.
• Experience in biopharmaceutical manufacturing environments.
• Familiar with cGMP, change control and CAPA processes.

Responsibilities

• Provide engineering support for design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L.
• Manage capital projects, retrofits and equipment acquisitions.
• Support technology transfer and scale-up activities.
• Lead resolution of technical issues with manufacturing operations.
• Collaborate with Validation, Automation, Quality, Metrology, Maintenance and Process Development.
• Apply process and utility system knowledge to improve efficiencies.
• Coordinate internal/external resources for timely, cost-effective projects.
• Act as SME and equipment owner for Upstream/Downstream equipment.
• Negotiate contracts, bids and change orders with vendors/contractors.
• Support CAPA investigations with key stakeholders.

Skills

Project management

Process engineering

Biopharmaceutical knowledge

Education

BS in Engineering

Job description

Samsung Biologics is seeking a Process Engineer at the Rockville site to provide technical engineering and project management for cGMP manufacturing, including capital projects, equipment optimization and tech transfer support. The role requires a BS in Engineering and hands-on coordination of design, testing, commissioning, and validation.

Experience with upstream/downstream equipment, CAPA, change control, and regulatory compliance is essential to drive process improvements and successful tech