Senior Sterilisation Engineer - Medtronic Athlone

Location:

Athlone, County Westmeath, Ireland

Requisition #:

20000EIX

Post Date:

Feb 18, 2021


MEDTRONIC


At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations


OUR PURPOSE


At Quality in Medtronic, plc, we focus on living the Medtronic mission by striving without reserve for unsurpassed product quality, reliability and patient safety through effective, agile and compliant processes.


The Senior Sterilization Engineer/Microbiologist requires strong knowledge of Ethylene Oxide Sterilization per ISO 11135 and is the site subject matter expert for the EO sterilization process associated cycles.


Come for a job, stay for a career!


A DAY IN THE LIFE:


Manage the Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and release of routine production loads.


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.


All activities must be performed in compliance with the Quality System.


KEY SKILLS EXPERIENCE


Required Education:


Bachelor of Science degree is required (Level 8). Masters degree in Microbiology or other life sciences is preferred.


Required Years of Experience:


5+ years of medical device industry experience in sterilization.


Required Knowledge


General maths, general and analytical chemistry knowledge.


Strong knowledge of Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and release of routine production loads.


Excellent technical writing skills.


Desired Qualifications


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 skills.


Medtronic offer a competitive Salary and flexible Benefits Package
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.