Cleanliness & Sterilization Manager

Job Description

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

Act as SME for cleanliness, disinfection and sterilization in New Product Introduction and throughout the whole lifecycle of products

Generate and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring these documents are accurate and comply with applicable engineering-, medical device- and Nobel Biocare standards

Perform cleaning and sterilization validation and product reusability assessment in order to provide validated instructions for use regarding cleaning, disinfection and sterilization

Support 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)

Review and update procedures related to product cleanliness

Perform sterilization (re)validation

Perform in process monitoring related to product cleanliness and the sterilization.

 #LI-MK1

Job Requirements:

In-depth knowledge of Quality Management System regulations and the regulations, directives and standards related to microbiology, cleanroom, chemistry and process validation, in particular:

ISO 13485 (Quality Management System for Medical Devices)

ISO 11137-1 and ISO 11137-2

ISO 10993-1

AAMI TIR35

AAMI ST72

ISO 11737-1, ISO 11737-2 and ISO 11737-3

ISO 14644 series

Strong background in Chemistry, Biology, Biomedical or Microbiology.

5+ years of experience in the field of cleanliness & sterilization in the medical device or pharmaceutical industry

Good track record in leading cleanliness & sterilization teams, projects, specifying sterile medical device requirements and conducting cleanliness & sterilization validations leading projects in matrix organizations in the medical device or pharmaceutical industry, preferably in the dental industry.

Comprehensive experience of manufacturing process needs to meet cleanliness requirements.

Fluency in English is mandatory, other languages are welcome.

Operating Company:

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.