Job Description

Key Responsibilities

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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

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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

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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