Lead Specialist, Sterilization and Microbiology - Exton, PA
Core
Lead specialist ensuring sterilization activities, contamination control, and microbiological safety for biomedical manufactured products.
Role type
Lead Specialist, Sterilization and Microbiology
Builds
Sterilized biomedical products and validated manufacturing processes
Domain
Medical Device / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterilization methods (gamma, Ebeam, EtO), Microbiological control, QA/QC, Environmental monitoring, ISO 13485 compliance, Validation authoring, Risk assessment
Preferred skills
Clean room experience, Zoonosis reporting, Viral inactivation studies
Technologies
Gamma sterilization, Ebeam, EtO, ISO 13485, ISO MDD
Responsibilities
Support sterilization activities including dose audits and EO requalification; Manage internal and sub-contracted testing programs for patient safety; Serve as technical liaison for microbiological testing functions and perform audits; Author and review validations for supplier compliance; Oversee Environmental Monitoring Program and controlled environment qualification; Support test method validations for bioburden and endotoxin testing; Perform gap analyses for regulatory standards compliance.
Seniority
Mid-level Specialist (3-5 years experience)