Sterility Assurance Engineer III — Validation & Compliance

Owens & Minor; Tallahassee (FL); Presencial; USD 100 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive Health Plan

Educational Assistance

Employer-Paid Life Insurance & Dis

Voluntary Supplemental Programs

Adoption & Fertility Benefits

HSA & 401(k)

Paid Leave & Holidays

Well-Being Programs

Resumo da oferta

Owens & Minor in the United States seeks a Quality Engineer III specializing in Sterility Assurance and Environmental Controls to lead validation activities for medical products. The role partners across functions to ensure sterilization processes meet quality and regulatory requirements.

You will develop protocols, coordinate sterilization qualifications, support change control, and contribute to continuous improvement of sterility and environmental-control programs.

Qualificações

• Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or related discipline.
• 5+ years in terminal sterilization, sterility assurance, microbiology, or related quality engineering.
• Experience with validation/qualification activities for medical products.

Responsabilidades

• Provides technical expertise in terminal sterilization, sterility assurance, and environmental controls.
• Develops and executes sterilization validation/qualification plans (ETO, gamma, e-beam).
• Supports product/material changes by evaluating sterilization requirements and risks.
• Creates documentation: protocols, reports, specifications and validation deliverables.
• Coordinates qualification activities for contract sterilization facilities and vendors.
• Ensures compliance with internal requirements, international standards, and regulatory expectations.
• Supports investigations for sterilization failures and deviations; assists CAPA activities.
• Reviews and updates sterilization-related documentation and quality-system records.

Conhecimentos

Sterility assurance

Quality engineering

Validation & qualification

Root-cause analysis

Environmental monitoring

Technical risk assessment

Cross-functional collaboration

Formação académica

Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or related

Descrição da oferta de emprego

Owens & Minor in the United States seeks a Quality Engineer III specializing in Sterility Assurance and Environmental Controls to lead validation activities for medical products. The role partners across functions to ensure sterilization processes meet quality and regulatory requirements.

You will develop protocols, coordinate sterilization qualifications, support change control, and contribute to continuous improvement of sterility and environmental-control programs.