Cleanliness and Sterilization Specialist
vor 1 Monat
Job Title: Cleanliness and Sterilization Manager
Job Summary:
We are seeking a highly skilled Cleanliness and Sterilization Manager to join our team at Envista. The successful candidate will be responsible for ensuring cleanliness and sterilization compliance of design control and manufacturing processes according to applicable standards.
Key Responsibilities:
- Act as Subject Matter Expert (SME) for cleanliness, disinfection, and sterilization in New Product Introduction and throughout the product lifecycle.
- Generate and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring accuracy and compliance with applicable standards.
- Perform cleaning and sterilization validation and product reusability assessment to provide validated instructions for use regarding cleaning, disinfection, and sterilization.
- Support cleanliness and sterilization SMEs on manufacturing sites to drive improvements, review and update procedures, perform sterilization validation, and in-process monitoring.
Requirements:
- In-depth knowledge of Quality Management System regulations and regulations related to microbiology, cleanroom, chemistry, and process validation.
- Strong background in Chemistry, Biology, Biomedical, or Microbiology.
- 5+ years of experience in cleanliness and sterilization in the medical device or pharmaceutical industry.
- Good track record in leading cleanliness and sterilization teams, projects, specifying sterile medical device requirements, and conducting cleanliness and sterilization validations.
- Comprehensive experience of manufacturing process needs to meet cleanliness requirements.
- Fluency in English is mandatory, other languages are welcome.
About Envista:
Envista and its family of companies are committed to providing innovative solutions for the dental industry. We are a global leader in the development, manufacturing, and marketing of dental products and services.
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