Associate Director of Engineering, Facilities
Core
Strategic leadership for Facilities Engineering, Maintenance, and Metrology departments to support CGMP manufacturing of gene therapies and vaccines.
Role type
Senior IC Associate Director of Engineering, Facilities
Builds
CGMP manufacturing suites, fill/finish, testing labs, and cold storage warehousing for AAV and viral vector-based therapies
Domain
Biopharma / Gene Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, FDA guidelines, capital project management, team leadership, root cause analysis, risk management (FMEA/FTA), validation lifecycle (IQ/OQ/PQ), CMMS management, SOP development, utility system expertise
Preferred skills
Catalent leadership program experience, cleanroom construction expertise
Technologies
CMMS, MS Office, laboratory-related software
Responsibilities
Lead and mentor high-performing teams in facilities engineering and technical trades; Define departmental strategies aligned with corporate goals; Oversee resource planning, talent development, and succession planning; Champion safety, quality, and compliance initiatives; Lead projects from start to finish including documentation and contractor oversight; Troubleshoot and repair bioprocess and facilities equipment (water generation, pure gas, boilers, chillers, HVAC); Review and approve qualification protocols and Standard Operating Procedures; Perform root cause analysis and support corrective and preventive actions; Serve as subject matter expert for expansion projects including cleanroom construction.
Seniority
Senior, hands-on IC with strategic leadership
