EO Sterilization Specialist

1 week ago

Bengaluru, Karnataka, India Pragathi IT Ads Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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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