Senior Specialist, Vaccines Technology
Core
Provide technical support for formulation, primary filling, inspection, and packaging operations at a vaccine manufacturing facility, acting as a subject matter expert for commissioning, tech transfer, startup, and validation.
Role type
Senior individual contributor process engineering specialist (vaccines)
Builds
Robust vaccine manufacturing processes and supply chain reliability
Domain
Biopharmaceuticals / Vaccines / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering, cGMP compliance, regulatory inspection support, root cause analysis, CAPA implementation, MES batch record management, change management, technical writing, project management
Preferred skills
Aseptic filling, CIP/SIP systems, serialization/aggregation, Lean Manufacturing, statistical data analysis, SAP/MES proficiency
Technologies
MES, SAP, Minitab, Excel
Responsibilities
Build robust processes for consistent vaccine supply; resolve and escalate technical issues impacting supply; manage MES batch records and facilitate changes; define Critical Process Parameters (CPP) to ensure quality attributes; act as SME during regulatory inspections; generate validation data for licensure; execute change management with scientific justification; investigate and implement CAPAs for compliance discrepancies; manage technical startup activities; recommend continuous improvement and capital projects; partner with Operations and Quality groups.
Seniority
Senior, hands-on IC