Facilities Engineer
Core
Ensuring manufacturing equipment and site utilities (process gases, HVAC, electrical, mechanical) are calibrated, maintained, and compliant with regulatory expectations for clinical development programs.
Role type
GMP Facilities Engineer
Builds
Manufacturing equipment and facility utilities for regenerative medicine clinical development
Domain
Biotechnology / Regenerative Medicine / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NIST standards, HVAC, Utility Systems (WFI, process gases), CMMS/Work Order ticket systems, BMS/automation, P&IDs, metrology programs, asset management, root-cause investigations, vendor coordination, GAMP5 standards, FDA/EMA inspection readiness
Preferred skills
Experience in metrology and facility engineering, mix of industry and educational background
Technologies
CMMS, BMS, HVAC systems, WFI systems, process gas systems
Responsibilities
Coordinate site-wide calibration and maintenance programs; Support Commissioning, Qualification, and Validation (CQV) of manufacturing equipment and facility utilities; Draft and maintain lifecycle documentation including Engineering Drawings; Monitor and support operations of building and clean utilities (HVAC, mechanical/electrical, process gases); Administer Computerized Maintenance Management System (CMMS) for asset tracking and PM schedules; Facilitate third-party contractor scheduling for calibrations and repairs; Assist in regulatory inspection readiness by organizing engineering and validation packages
Seniority
Mid-level, hands-on IC
