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
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