
EO Sterilization Specialist
1 week ago
Key Responsibilities:
- Operate, monitor, and maintain Ethylene Oxide (EO) sterilization equipment in accordance with validated procedures and safety regulations.
- Ensure all sterilization processes comply with ISO 11135, ISO 13485, and regulatory requirements.
- Prepare loads, monitor sterilization cycles, and verify process parameters.
- Perform biological and chemical indicator testing to confirm sterilization efficacy.
- Maintain accurate documentation and sterilization records for audits and inspections.
- Troubleshoot equipment and process deviations, implementing corrective and preventive actions (CAPA).
- Collaborate with Quality Assurance, Production, and Regulatory teams to ensure compliance.
- Support validation activities for new products and equipment.
Requirements:
- Bachelor's degree or diploma in Microbiology, Biomedical Engineering, or related field.
- Minimum 2–3 years of experience in EO sterilization within a medical device or pharmaceutical manufacturing environment.
- Strong knowledge of EO sterilization principles, equipment, and validation requirements.
- Familiarity with ISO 11135, ISO 13485, and FDA/GMP guidelines.
- Excellent documentation and communication skills.
- Strong problem-solving skills and attention to detail.
Benefits:
- Competitive salary and benefits package.
- Professional development and training opportunities.
- Opportunity to work in a high-quality, regulated manufacturing environment
Job Types: Full-time, Permanent
Work Location: In person
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