Cleanliness and sterility assurance Engineer
On-site · Karlskoga, Örebro, Sweden or Yorba Linda, California, United States
Job Summary
The Cleanliness and Sterility Assurance Engineer is responsible for supporting the cleanliness and sterility assurance of medical devices, defining validation studies for microbiological/physical/chemical cleanliness for new equipment, performing cleanliness process validation, and defining monitoring activities with the contamination control manager. This role requires a strong technical background in relevant fields, 5 years of MedTech experience, knowledge of contamination control standards, and proficiency in statistical data analysis and communication skills.
Required Qualifications
- 5 years of experience in MedTech industry or equivalent
- Strong technical background (MSc or equivalent) in relevant field (Biotechnology or Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry or related science)
- Solid knowledge of regulatory requirements and standards related to contamination control and cleanliness control
- Solid understanding of manufacturing environment and process validation
- Fluent in English (spoken and written), Swedish is an asset
Desired Qualifications
- Strong analytical skills
- Solid expertise in statistical data analysis
- Excellent verbal & written communication skills
Additional Requirements
- Envista and its family of companies will not accept unsolicited resumes from any source other than directly from a candidate.
- An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes.
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