Director of Engineering, Facilities, and Validation
Core
Lead a multi-disciplinary group responsible for maintaining and advancing state-of-the-art gene therapy development and manufacturing facilities, ensuring reliability, compliance, and continuous improvement for all site assets.
Role type
Director of Engineering, Facilities, and Validation
Builds
CGMP manufacturing suites, fill/finish lines, testing labs, and cold storage warehousing for AAV and viral vector-based therapies and vaccines
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Required skills
cGMP compliance, capital expenditure management, lean transformation, maintenance optimization, HVAC and clean utility systems, automation control systems, project management, budgeting and forecasting, FDA regulations knowledge, leadership and talent development
Preferred skills
Gene therapy experience
Technologies
Computerized Maintenance Management System (CMMS), automation control systems, data collection/retention systems
Responsibilities
Oversee management of buildings, equipment, and grounds; manage capital and non-capital projects to improve capacity and efficiency; lead long-term capital planning and departmental budgeting; implement lean transformation initiatives; drive projects to maximize output and enhance EHS performance; ensure compliance with cGMP regulations and environmental requirements; maintain compliance with planned maintenance and calibration schedules; collaborate with Manufacturing and Quality teams to ensure equipment and facilities are available and reliable.
Seniority
Director, strategic and operational leadership