Senior Facilities Engineer

Responsibilities

• Provide technical and quality ownership of facility and utility systems including on-site troubleshooting and investigations
• Improve preventative maintenance programs and strategies within the CMMS to maximize reliability
• Use reliability-centered maintenance concepts and data to prioritize efforts and system optimizations
• Act as the main engineering point of contact for facility and utility projects from design through commissioning and validation
• Serve as a subject matter expert for investigations of equipment system deviations and drive CAPA implementation
• Own and execute change management for facility and utility systems
• Support the development and revision of governing system and equipment SOPs
• Mentor and train junior team members

Requirements

• Bachelor of Science in Chemical, Mechanical, or related engineering field
• 8-10 years of experience in Utilities/Plant Engineering or related functions in a cGMP manufacturing environment
• Demonstrated leadership in executing projects within FDA/EMA regulated environments
• Experience at a biologic or advanced therapy medicinal product (ATMP) manufacturing site
• Knowledge of cGMP engineering design, commissioning, and validation
• Experience with Computerized Maintenance Management Systems (e.g., Blue Mountain RAM, Maximo, EAM)
• Proficiency with quality systems including change controls, CAPAs, and deviations
• Ability to stand for extended periods, climb ladders, and lift up to 50lbs
• Ability to work in controlled environments requiring GxP gowning

About the Company

Ultragenyx is a biopharmaceutical company dedicated to leading the future of rare disease medicine by developing life-changing treatments through a novel rapid development approach.