Job Description
Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products.
Responsibilities:
- Develop, execute, and document IQ/OQ/PQ validation protocols for ETO sterilization processes.
- Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations.
- Analyze microbiological, physicochemical, and process performance data.
- Ensure compliance with applicable standards such as ISO 11135, ISO 10993...
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