cGMP Facilities Coordinator
Core
Oversee cGMP lab and ancillary space operations, maintenance, qualification, and validation to support cell and gene therapy development.
Role type
Facilities Coordinator (cGMP)
Builds
cGMP facilities and biological product development environments
Domain
Life Sciences / Biotechnology / cGMP
Deliverable
physical/clinical work
Required skills
cGMP compliance, facility operations, equipment commissioning and validation, preventive maintenance, risk assessment, root cause analysis, CAPA implementation, laboratory procedures, microbiological culture, media formulation, budget management, contractor supervision
Preferred skills
specialized scientific field knowledge, computer software for record maintenance
Technologies
HVAC systems, fire alarm systems, plumbing systems, laboratory equipment, Elisa plate testing
Responsibilities
Perform repairs, emergency, and preventive maintenance on facility systems and equipment; oversee and inspect outside contractors; perform equipment commissioning, qualification, and validation; conduct moderate to complex laboratory procedures and testing; supervise unit employees in the absence of the Facilities Manager; coordinate environmental health and safety programs; coordinate construction and renovation projects; monitor and analyze facilities expenses.
Seniority
Mid-level, hands-on IC
