The Plant Microbiologist has the responsibility and authority to provide scientific support for microbiological evaluation of medical devices, processes and materials.
The position will be responsible for completion of sterilization validations(s) and cleanroom microbiological evaluations. The position provides technical guidance to engineers and /or project management. This position requires knowledge of ethylene oxide sterilization per ISO 11135 and the Microbiologist should have strong report writing skills.
• Manages the sterilization and microbiological testing necessary to meet manufacturing and regulatory requirements
• Responsible for maintaining compliance to all regulations and standards relevant to job responsibilities
• Manage technical projects from protocol development, laboratory testing, data analysis through final report generation
• Manage environmental trending as required by regulations to ensure compliance for critical systems
- Develops, validates, and implements controlled environment methods
• Perform various microbiological or chemical evaluations encompassing USP/AAMI biological testing, ETO residuals and other alternative sterilization methods
• Provides technical support for new product development and manufacturing processes related to microbiological quality
• Meets and occasionally exceeds the duties and responsibilities of the job and of Medtronic Core Competencies
• All activities must be performed in compliance with the Quality System
KEY SKILLS & EXPERIENCE
Bachelor of Science degree is required (Level 8). Master’s degree in Microbiology or other life sciences is preferred.
Required Years of Experience
5+ years of medical device industry experience in microbiology and sterilization
• General maths, general and analytical chemistry knowledge
• Microbiology laboratory skills
• Knowledge of Ethylene Oxide Sterilisation as per ISO 11135. This includes validations, re-qualifications, and routine production.
• Knowledge of industrial microbiology, microbiological quality control, medical device sterilization methods, and medical device GMPs.
• Knowledge of applied microbiological theory and practices including inactivation kinetics, and medical device sterilization methods.
• Microbiology laboratory skills including volumetric measurement, media preparation, microbial enumeration techniques, autoclave operation and laboratory safety.
- Basic maths, algebraic maths, with ability to calculate serial dilutions, scientific exponents, proportional concentrations and graphing skills.
• Knowledge of Cleanroom environmental monitoring.
• Computer skills
• Good oral and written communication skillsFor more information please call me on 087 9728431 or Annemarie@amfconsulting.ie
To apply for this job email your details to firstname.lastname@example.org