Microbiology and Sterilization Specialist

About the role

LiNA Medical Polska, a manufacturer of minimally invasive gynaecological medical devices, was looking for a Microbiology and Sterilization Specialist for its Poznań site. The recruitment has ended and the listing is now archived, but the job description remains available.

Key responsibilities

• Overall responsibility for microbiology analysis of products, raw materials, clean room environment and personnel
• Keep up to date with regulatory requirements and standards in the field
• Take part in and perform clean room qualification according to standards such as ISO 13485, ISO 14644 and EN 17141
• Supervise maintenance of cleanroom class requirements and controlled environment, including physical parameters, equipment cleanliness and clothing
• Perform analysis of environment and personnel contamination
• Take part in risk assessment and review microbiology and particle data from external sources
• Take part in and coordinate the external ETO sterilization process and liaise with the sterilization service provider
• Review and approve validation protocols and reports (ISO 11135, ISO 11137)
• Create and update quality documentation and follow OOS and NC procedures
• Train staff on microbiological, sterilization and clean room topics

Required profile

• Relevant education and/or experience
• Experience in the medical devices or pharmaceutical industry is an advantage
• Experience in a laboratory is an advantage
• Fluent English, spoken and written
• Category B driving licence

Required skills

• Familiarity with ETO sterilization
• Familiarity with ISO 13485, ISO 11135, ISO 11137 and ISO 14644
• Experience in the microbiological area
• User-level IT skills