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:
Benefits
Dental insuranceVision insurance
Additional Information
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).
Envista · Värmland, Karlskoga, Sweden