JOB DESCRIPTION:

Responsible for microbiological cleanliness & sterilization compliance of design control and manufacturing processes according to the applicable standards.

• Act as SME for for microbiological cleanliness, disinfection, and sterilization of both single-use and reusable products during New Product Introduction (NPI) and throughout the entire product lifecycle.
• Evaluate product and process changes for impact on Sterility Assurance.
• Contribute to the creation and evaluation of technical sterilization and microbial cleanliness specifications within the context of Technical Files. Ensure that these documents are precise and align with relevant engineering, medical device, and Nobel Biocare standards.
• Develop and execute cleaning and sterilization validation, along with product reusability assessments. These efforts aim to establish validated instructions for use related to cleaning, disinfection, and sterilization.
• Ensure company documentation related to sterilization are maintained and updated with most current regulations, standards, and industry practices.
• Develop a strong interface with cleanliness and sterilization Subject Matter Experts on the manufacturing sites to:
• Drive improvements to enhance product cleanliness (cleanroom set-up, product final cleaning, tool cleaning etc)

• Ensure that the manufacturing and sterilization process effectiveness monitoring is performed in compliance with regulatory requirements.

  LI-MK1

CRITICAL KNOWLEDGE AND QUALIFICATIONS:

• Minimum Bachelor’s degree in a relevant scientific discipline (preferably microbiology).
• Industry Experience: Preferably 2 years in product sterilization within medical device or pharmaceutical sectors
• Data Analysis: Strong statistical expertise.
• Demonstrated ability to understand and apply relevant regulatory standards (or ability to rapidly develop expertise to function independently with minimal supervision) including but not limited to:
• Cleaning and sterilization: ISO 11137-1&2&3, ISO 17665-1,2,3, and AAMI ST98.
• Quality Management: ISO 13485

CRITICAL SKILLS/TECHNICAL KNOW-HOW:

• Fluency in English is mandatory, other languages are welcome.
• Comprehensive experience of manufacturing process needs to meet cleanliness requirements.
• Systematic and standardized approach to improve processes or solve problems
• Project Management experience

• Act as SME for for microbiological cleanliness, disinfection, and sterilization of both single-use and reusable products during New Product Introduction (NPI) and throughout the entire product lifecycle.
• Evaluate product and process changes for impact on Sterility Assurance.
• Contribute to the creation and evaluation of technical sterilization and microbial cleanliness specifications within the context of Technical Files. Ensure that these documents are precise and align with relevant engineering, medical device, and Nobel Biocare standards.
• Develop and execute cleaning and sterilization validation, along with product reusability assessments. These efforts aim to establish validated instructions for use related to cleaning, disinfection, and sterilization.
• Ensure company documentation related to sterilization are maintained and updated with most current regulations, standards, and industry practices.
• Develop a strong interface with cleanliness and sterilization Subject Matter Experts on the manufacturing sites to:
• Drive improvements to enhance product cleanliness (cleanroom set-up, product final cleaning, tool cleaning etc)
• Ensure that the manufacturing and sterilization process effectiveness monitoring is performed in compliance with regulatory requirements