Engineer, Facilties
Core
Engineer, Facilities providing engineering support for critical utilities in GMP manufacturing of gene therapies and vaccines.
Role type
Facilities Engineer (GMP Manufacturing)
Builds
Reliable utility systems (WFI, purified water, clean steam, HVAC) supporting patient-critical manufacturing.
Domain
Biopharmaceutical manufacturing / Gene therapies
Required skills
cGMP regulatory knowledge, Clean Utility Systems (WFI, purified water, clean steam, HVAC), P&ID and GA drawings, IQ/OQ/PQ testing, 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), laboratory equipment software
Responsibilities
Advise on design, implementation, and commissioning of utility equipment; Author and review protocols and SOPs; Create design specifications and automation control strategies; Write technical documentation for FATs, SATs, and qualification testing; Provide technical solutions to facility problems; Perform investigations of manufacturing deviations; Perform utility monitoring and statistical analysis
Seniority
Mid-level, hands-on IC