Facilities Engineer
Core
Develop and execute validation protocols for new or upgraded facilities and utilities supporting medical device manufacturing.
Role type
Facilities Engineer (Validation & Commissioning)
Builds
Qualified clean rooms, HVAC, water systems, and environmental monitoring systems for regulated manufacturing.
Domain
Medical device manufacturing / Life Sciences
Required skills
Validation protocol design, HVAC systems engineering, Clean room management, Water system validation, Environmental monitoring (BMS/EMS), FDA cGMP regulations, Report writing, Change control assessment, Cross-functional coordination
Preferred skills
New facility commissioning experience, Direct FDA interaction experience
Technologies
HVAC, BMS, EMS, Environmental Monitoring Systems
Responsibilities
Develop and execute validation plans for facilities and utilities; Generate design specifications and engineering documentation; Prepare and execute protocols for HVAC, clean rooms, and utilities; Compile and analyze validation data; Investigate and troubleshoot qualification problems; Assess impact of change controls; Coordinate schedules with functional groups and vendors.
Seniority
Mid-level, hands-on IC