Engineer II, Facilities
Core
Operate, maintain, and improve GMP facilities, utilities, and infrastructure to ensure safe, reliable, and compliant manufacturing operations for advanced therapies.
Role type
Senior IC Facilities Engineer (GMP Biotech)
Builds
GMP-compliant manufacturing environments for Cell Therapy and Viral Vector clinical manufacturing
Domain
Biotechnology / Life Sciences / GMP Manufacturing
Deliverable
physical/clinical work
Required skills
GMP facility operations, utility system troubleshooting, root cause analysis, HVAC system knowledge, water/steam/gas system management, commissioning and validation support, change control management, CAPA management, CMMS asset management, engineering drawing review, shutdown planning, predictive maintenance, technical writing for SOPs, regulatory audit defense
Preferred skills
Experience with automated control systems, PLCs, HMIs, capital project management, safety program leadership
Technologies
HVAC systems, CMMS, PLCs, HMIs, Building Management Systems, Biokill waste processing systems, pH neutralization systems
Responsibilities
Troubleshoot equipment and utility systems with root cause analysis; support engineering lifecycle processes for GMP HVAC and base building utilities; lead walk downs of engineering drawings and perform commissioning test protocols; manage quality events for change control, CAPAs, and deviations; support facility and utility shutdown and expansion planning; lead technical writing for SOPs and engineering specifications; participate in project teams through design, construction, startup, and validation phases.
Seniority
Mid-Senior, hands-on IC
