Principal Project Engineer

Samsung Biologics•Rockville, MD

35d•$140,000 - $186,000•Onsite

About The Position

Samsung Biologics is seeking a Principal Project Engineer to provide technical engineering leadership and subject matter expertise to the Capital Projects group at their biopharmaceutical manufacturing site in Rockville. This role will support renovations, new construction, and the installation of facility-related equipment, acting as the lead technical consultant for medium-to-large capital investments. The engineer will approve technical specifications, ensure designs meet process requirements and regulatory standards, and manage the project lifecycle from conceptual design to Detailed Design. This includes overseeing external A&E firms to ensure deliverables meet site standards. Expertise in upstream/downstream processing, clean utilities (WFI, clean steam), and HVAC/ISO cleanroom requirements is crucial. The role involves partnering with Project Managers to define scope, estimate costs, and develop execution strategies that minimize disruption to operations. Technical risk assessments (FMEA) and safety reviews (HAZOP) will be conducted to identify and mitigate potential design flaws or safety hazards. The engineer will oversee implementation schedules and ensure projects are completed by deadlines, collaborating with various manufacturing support groups. Demonstrated project management skills and the ability to negotiate contracts, bids, and change orders are also required.

Requirements

Bachelor’s degree in engineering discipline (Chemical, Mechanical, Biological or similar)
10 years or more of relevant experience working in a regulated cGMP biopharmaceutical environment.
In-depth understanding and knowledge of biopharmaceutical production equipment including but not limited to bioreactors, centrifuges, CIP skids, chromatography systems and filtration skids.
Experience supporting batch and continuous industrial control systems including DeltaV
Experience with technical risk assessments and product control strategies
Demonstrated understanding of ASME BPE and ISPE guides
Good general background of interior and exterior commercial construction activities with some degree of understanding of all trades to support construction efforts.
Demonstrated project management skills (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.

Responsibilities

Provide technical engineering leadership and subject matter expertise to the Capital Projects group.
Act as the lead technical consultant for medium-to-large capital investments.
Approve technical specifications and ensure designs meet process requirements and regulatory standards.
Manage the full project lifecycle from conceptual design (Basis of Design) through Detailed Design.
Oversee external Architecture and Engineering (A&E) firms to ensure deliverables meet site standards.
Provide deep-dive expertise in upstream / downstream processing, clean utilities (WFI, clean steam), and HVAC / ISO cleanroom requirements.
Partner with Project Managers to define scope, estimate costs (Class 1 – 5) and develop execution strategies.
Lead the technical risk assessment (FMEA) and safety reviews (HAZOP).
Oversee the overall implementation schedule for assigned capital projects and ensure timely completion.
Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and MSAT.
Demonstrate project management skills (schedule, cost, communications) and coordination of internal and external resources.
Effectively negotiate contracts, bids and change orders with vendors or contractors.