Sterility & Cleanliness Validation Engineer

Nobel Biocare; Karlskoga kommun; On-site; SEK 900,000 - 1,100,000; Full time

Job summary

Nobel Biocare AB in Karlskoga, Sweden, is seeking a Cleanliness & Sterility Assurance Engineer to support the cleanliness and sterility of dental implant products manufactured at our Karlskoga site and Yorba Linda, USA.

The role focuses on regulatory compliance, quality, and safety, with responsibilities spanning validation studies, process validation, monitoring, documentation, and collaboration with cross-functional teams to drive continuous improvement.

Qualifications

• Master’s degree in Biotechnology, Biomedical Engineering, Microbiology, or related field.
• Minimum 5 years in Medical Device industry or regulated environment.
• Strong knowledge of contamination control and cleanliness assurance.
• Experience with ISO 13485 and ISO 11137-1 & 2.
• Understanding of manufacturing processes and validation methodologies.
• Excellent communication skills and English fluency (Swedish a plus).

Responsibilities

• Define validation studies for microbiological, physical, and chemical cleanliness.
• Lead cleanliness process validations for new/modified equipment.
• Develop and implement cleanliness monitoring with Contamination Control Manager.
• Maintain contact material mapping documentation.
• Establish procedures and templates for standardized validation and monitoring.
• Support biological and microbiological safety strategies.
• Coordinate external testing with laboratories and vendors.
• Collaborate with cross-functional teams for continuous improvement and compliance.

Skills

Communication skills

Analytical mindset

Statistical analysis

English fluency

Education

Master’s degree (MSc) in Biotechnology, Biomedical Engineering, Microbiology, or related field

Job description

Nobel Biocare AB in Karlskoga, Sweden, is seeking a Cleanliness & Sterility Assurance Engineer to support the cleanliness and sterility of dental implant products manufactured at our Karlskoga site and Yorba Linda, USA.

The role focuses on regulatory compliance, quality, and safety, with responsibilities spanning validation studies, process validation, monitoring, documentation, and collaboration with cross-functional teams to drive continuous improvement.