Cleanliness and Sterility Assurance Engineer
Envista Holdings Corporation
full-time
Posted on:
Location Type: Hybrid
Location: Karlskoga • Sweden
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About the role
- 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)
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 (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
Benefits
- No unsolicited resumes accepted from agencies
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
microbiological cleanlinessprocess validationcontamination controlstatistical data analysisregulatory requirementsISO 13485ISO 11137-1ISO 11137-2cleanliness monitoringtechnical background in Biotechnology
Soft Skills
analytical skillsverbal communicationwritten communicationorganizational skillscoordination skills