Senior Biological Product Safety Specialist - Cleanliness expert

at  Nobel Biocare

JOB DESCRIPTION:

We are recruiting Senior Biological Product Safety Specialist based in our Headquarter in Zurich (Switzerland) or in our Manufacturing in Karlskoga (Sweden) focusing on the correlation between manufacturing processes and final product chemical cleanliness. He/She will be the responsible in translating and linking in-process and final product chemical cleanliness requirements with the necessary standards for biological safety in both validation and routine production.

The main responsibilities:

CRITICAL KNOWLEDGE AND QUALIFICATIONS:

• Strong technical background (MSc or equivalent) in relevant field (Biotechnology or Biomedical Engineering, Toxicology, Biology, Chemistry or related science
• Understanding of ISO 10993 biocompatibility standards.
• Broad understanding of ASTM F3127-22, ASTM F2847-17.
• Broad understanding of manufacturing environment and process validation
• Understanding of ISO 13485 and ISO 14971.
• Understanding of bone and/or mucosa biology, pharmacology and biochemistry.
• Fluent in English (spoken and written), German (spoken and written) is an asset.

CRITICAL SKILLS/TECHNICAL KNOW-HOW:

• A systematic and result-oriented work style.
• Good knowledge in relevant tools (SAP, MS Office), processes (DCP and ItM) and relevant SOPs
• Good internal knowledge of the relevant Nobel Biocare products, their materials, manufacturing methods and limitations.
• Strong analytical skills
• Pro-active and independent working style with a strong sense of responsibility and problem solving working attitude

CRITICAL EXPERIENCE:

• 5+ years relevant experience working in a regulated environment, preferably in the Dental Medical Device Industry.
• Experience to work cross-functionally and in multi-cultural teams (matrix organizations).

Please refer the Job description for details