Technical SME & Project Lead
Core
Provide technical expertise across manufacturing processes and technologies to support new product introductions, optimize operations, and resolve technical challenges in a biologics/pharmaceutical environment.
Role type
Senior IC Technical SME & Project Lead
Builds
Manufacturing processes, equipment upgrades, and new product introductions for biologics and pharmaceuticals
Domain
Biopharmaceuticals / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biologics/pharmaceuticals/medical device manufacturing experience, regulatory compliance knowledge, aseptic processing expertise, sterilization process knowledge, process improvement leadership, cross-functional collaboration
Preferred skills
aseptic filling operations experience, cleanroom technologies, change control/CAPA support, vendor management
Technologies
Steam sterilization, Ethylene Oxide (ETO), Gamma sterilization, Vaporized Hydrogen Peroxide (VHP), Lyophilization, Depyrogenation, Filtration
Responsibilities
Act as operations point of contact for site projects involving new technologies or products; Provide technical support for day-to-day manufacturing queries including change controls and CAPAs; Lead process improvement initiatives focused on reliability, efficiency, and cost reduction; Provide technical expertise for sterilization, cleaning, depyrogenation, and lyophilization processes; Act as technical authority for aseptic processing operations; Collaborate with cross-functional teams to implement innovative solutions.
Seniority
Mid-Senior, hands-on IC with project leadership