Job Title: Site Microbiologist - EO Sterilization Engineer
Our Client pride themselves on engineering the extraordinary. Valuing what makes you unique they are inviting you to be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations Our Client’s Purpose
At their Quality Department in their state-of-the-art facility in Athlone, they focus on living their company mission by striving without reserve for unsurpassed product quality, reliability and patient safety through effective, agile and compliant processes. The Site 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
• 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 Company Core Competencies
• All activities must be performed in compliance with the Quality System
Bachelor of Science degree 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 math, 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 math, algebraic math, 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 skills