Senior Sterilization Engineer
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Senior Sterilization Engineer (US MNC, Medical Devices)
Join an established global medical device manufacturer and play a key role in sterilization process validation, quality assurance and continuous improvement, ensuring product safety and compliance with international regulatory standards.
Key Responsibilities:
- Lead Ethylene Oxide (EO) sterilization validation and requalification activities.
- Develop and execute validation protocols, technical reports and sterilization documentation.
- Support process improvements, equipment qualification and manufacturing operations.
- Investigate process deviations, conduct root cause analysis and implement CAPA.
- Maintain sterilization process controls, risk assessments and microbiological monitoring.
- Collaborate with global Engineering, Quality, Manufacturing and Regulatory teams.
- Ensure compliance with ISO 11135, ISO 13485 and FDA requirements.
Requirements:
- Min Degree in Engineering, Microbiology, Biotechnology or related technical disciplines.
- Minimum 2 years of relevant experience in sterilization, validation, quality engineering or regulated manufacturing.
- Hands-on EO sterilization experience and knowledge of validation processes.
- Familiarity with ISO 11135, ISO 13485, GMP or FDA regulatory requirements.
- Experience preparing validation protocols, reports and quality documentation.
- Knowledge of CAPA, FMEA, microbiological testing or Minitab is advantageous.
- Strong communication and cross-functional stakeholder management skills.
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