Principal Project Engineer

Join Samsung Biologics’ biopharmaceutical manufacturing site in Rockville as a Principal Project Engineer. In this role, you will provide technical engineering leadership and subject matter expertise to the Capital Projects group, supporting renovations, new construction, and the installation of facility-related equipment.

• Act as the lead technical consultant for medium-to-large capital investments (e.g. facility expansions, renovation and new construction). You will approve technical specifications and ensure designs meet both process requirements and regulatory standards.

• Manage the full project lifecycle from conceptual design (Basis of Design) through Detailed Design. This includes overseeing 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 that minimize disruption to ongoing commercial operations.

• Lead the technical risk assessment (FMEA) and safety reviews (HAZOP) to identify and mitigate potential design flaws or safety hazards early in the project lifecycle.

• Oversee the overall implementation schedule for assigned capital projects and take necessary action to ensure all assigned capital projects are completed and turned over to internal customers with pre-established deadlines.

• Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and MSAT.

• Demonstrated project management skills (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.

• Capable of effectively negotiating contracts, bids and change orders with vendors or contractors.

Qualifications:

• 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