Engineer, Facilties
Core
Design, scale, and enhance critical utility systems (WFI, purified water, clean steam, HVAC, clean gas) to support GMP manufacturing of gene therapies and vaccines.
Role type
Facilities Engineer (GMP Utilities)
Builds
Reliable utility infrastructure for CGMP manufacturing suites
Domain
Biopharmaceutical manufacturing / Gene therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure
Required skills
cGMP regulatory knowledge, Clean Utility Systems design (WFI, PW, Steam, HVAC, Gas), P&ID and GA drawings, IQ/OQ/PQ validation, deviation investigation, statistical analysis
Preferred skills
Biotech/pharma industry experience, biochemical and molecular assays (ddPCR, qPCR, ELISA), cell-based assays, separation assays (HPLC, CE-SDS)
Technologies
MS Office (Excel, Word), P&ID software, GA drawing tools, laboratory equipment software
Responsibilities
Advise on design, implementation, and commissioning of utility equipment; Author and review protocols/SOPs for qualification and validation; Create design specifications and automation control strategies; Write technical documentation for FAT/SAT/IQ/OQ/PQ; Provide technical solutions for equipment failures; Perform utility monitoring and statistical analysis
Seniority
Mid-level, hands-on IC
