Engineer II, Facilities
Core
Support the operation, maintenance, and continuous improvement of GMP facilities, utilities, and infrastructure to ensure safe, reliable, and compliant manufacturing operations for Cell Therapy and Viral Vector clinical manufacturing. (via careerplan.io/jobs/6219425004-engineer-ii-facilities-at-elevatebio)
Role type
Senior IC facilities engineering specialist (GMP biotech)
Builds
GMP-compliant manufacturing environments and utility systems
Domain
Biotechnology / Life Sciences / GMP Manufacturing
Deliverable
physical/clinical work
Required skills
HVAC systems knowledge, GMP compliance, root cause analysis, CMMS management, commissioning and validation, change control and CAPA management, technical writing, regulatory audit support, automated control systems (PLC/HMI), shutdown planning, capital project support, predictive maintenance
Preferred skills
Experience presenting and defending Facilities Engineering in Regulatory Audits
Technologies
HVAC, PLC, HMI, CMMS, Building Management Systems, Piping and Instrumentation Diagrams (P&ID)
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 planning and expansion; Lead technical writing for SOPs and engineering specifications; Collaborate cross-functionally with Validation, Quality, and Automation teams.
Seniority
Senior, hands-on IC