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

The anticipated salary range for this position in Maryland is $140K to $186K plus 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 benefits effective day one of employment