Validation Engineer Sterilization (MS&T)
Core
Subject matter expert for sterilization processes, specifically leading validation and qualification of autoclaves and VHP decontamination systems to ensure compliance and patient safety.
Role type
Senior Validation Engineer (Sterilization)
Builds
Validated sterilization systems and processes for pharmaceutical/dermatology manufacturing
Domain
Pharmaceutical manufacturing / Sterilization Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Autoclave validation, VHP decontamination systems, IQ/OQ/PQ execution, thermal mapping, heat penetration studies, biological indicator evaluation, lifecycle management, risk assessment, regulatory compliance (cGMP), technical writing
Preferred skills
Experience in GMP-regulated environments (pharma/biopharma/medical devices), root cause analysis, stakeholder influence
Technologies
Autoclaves, VHP systems, isolators, controlled environments
Responsibilities
Lead autoclave cycle development, qualification, and validation; Plan and execute equipment/process qualification (IQ/OQ/PQ); Perform thermal mapping and biological indicator evaluations; Author and approve validation protocols, reports, and change controls; Drive requalification programs and lifecycle management.
Seniority
Senior, hands-on IC
