Principal Project Engineer
$140,000–$186,000 year
On-site · Rockville, Maryland, United States
Job Summary
Lead technical engineering for Capital Projects at a Samsung Biologics biopharmaceutical manufacturing site in Rockville. Provide engineering leadership for medium-to-large capital investments including renovations, new construction, and installation of facility-related equipment. Act as lead technical consultant for design deliverables, approve specifications, and ensure designs meet process requirements and regulatory standards. Manage full project lifecycle from Concept (Basis of Design) to Detailed Design, overseeing external Architecture and Engineering firms to ensure site standards. Provide deep-dive expertise in upstream/downstream processing, clean utilities (WFI, clean steam), and HVAC/ISO cleanroom requirements. Collaborate with Project Managers to define scope, estimate costs (Class 1–5), and develop execution strategies that minimize disruption to operations. Lead technical risk assessments (FMEA) and safety reviews (HAZOP) to identify and mitigate design flaws or hazards early. Oversee implementation schedules and ensure turnover to internal customers by deadlines. Coordinate with Validation, Automation, Quality, Metrology, Maintenance and MSAT; negotiate contracts and change orders with vendors or contractors.
Required Qualifications
- Bachelor’s degree in engineering (Chemical, Mechanical, Biological or similar)
- 10 years or more of relevant experience in a regulated cGMP biopharmaceutical environment
- Experience with biopharmaceutical production equipment including bioreactors, centrifuges, CIP skids, chromatography systems and filtration skids
- Experience with DeltaV or similar industrial control systems
- Demonstrated ability in technical risk assessments (FMEA) and product control strategies
- Strong understanding of ASME BPE and ISPE guides
- Experience coordinating with internal and external stakeholders (Validation, Automation, Quality, Metrology, Maintenance, MSAT) and negotiating contracts/bids
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