Cleanliness and sterility assurance Engineer

Job Description:

The Cleanliness and sterility assurance Engineer is responsible for supporting the cleanliness and sterility
assurance of medical devices for our dental implant manufacturing in Karlskoga (Sweden) and Yorba Linda (USA).

Responsibilities:

• Define validation studies with respect to microbiological/physical/chemical Cleanliness for new equipment and equipment changes
• Perform cleanliness process validation of updated/new equipment
• Define cleanliness monitoring activities for updated/new equipment together with contamination control manager
• Maintain contact material mapping
• Build and maintain a framework of procedures and templates to ensure standard work for the cleanliness validation and monitoring activities.
• Support the biological and microbiological safety strategy
• Plan and coordinate external tests execution with approved vendors (at need).

#LI-PG1

Job Requirements:

• Strong technical background (MSc or equivalent) in relevant field (Biotechnology or Biomedical Engineering,
  Microbiology, Toxicology, Biology, Chemistry or related science)
• 5 years of experience in MedTech industry or equivalent
• Solid knowledge of regulatory requirements and standards related to contamination control and cleanliness
  control or ability to rapidly develop expertise to function independently with minimal supervision (ISO 13485, ISO 11137-1&2)
• Solid understanding of manufacturing environment and process validation
• Solid expertise in statistical data analysis 
• Fluent in English (spoken and written), Swedish is an asset.
• Excellent verbal & written communication skills
• Strong analytical skills

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.