Microbiology and Sterilization Specialist – Praca na etat, Poznań Sady

List of responsibility:

• Overall responsibility for microbiology analysis of products, raw materials, clean room environment and personnel
• Being up to date with regulatory requirements and standards within area of responsibility
• Participation and performing clean room qualification according to related standards (e.g. ISO 13485, ISO 14644, EN 17141)
• Supervision of maintaining of cleanroom class requirements and associated controlled environment
• Supervision of clean room physical parameters, cleanliness of clean room equipment and clothing
• Perform analysis of environment and personnel contamination
• Participation in risk assessment process
• Review of microbiology/particles data from external origin
• Participation and coordination of ETO Sterilization external process
• Being in contact with sterilization service provider
• Review and approval process for validation of sterilization (protocols and reports) – ISO 11135, ISO 11137
• Creation and update of the quality documentation according to the quality standards implemented within the company
• Follow the OOS procedure/NC procedure
• Training of employees from all microbiological / sterilization / Clean room related issues

Qualifications and competences:

• Fast learning and open minded
• Excellent communication skills
• Efficient, accurate, work according to plan
• Flexible and pro-active
• Positive & problem solving attitude
• Relevant education and/or experience
• Work experience within Medical Devices or Pharmaceutical industry is an advantage
• Experience in laboratory is an advantage
• Familiar with ETO sterilization method
• Familiar with ISO 13485, ISO11135, ISO11137, ISO14644)
• Experience in microbiological area
• Fluent English – verbal and written
• IT on a user level
• Driving license cat.B