Cache of job #14130448

Job Title

Senior SterilISAtion Engineer


CareerWise Recruitment




A Senior Sterilisation Engineer is required by CareerWise Recruitment for our client based in Athlone, Co. Westmeath. The Senior Sterilisation Engineer 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 ETO sterilization per ISO 11135 and strong Audit skills. Please contact Tom Devaney for more information. THE ROLE: * 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 the Corporate Core Competencies. * All activities must be performed in compliance with the Quality System. REQUIREMENTS: * Bachelor of Science Degree is required (Level 8). Master's degree in Microbiology or other life sciences is preferred. * 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, Excellent Computer skills & Good oral and written communication skills. Please call Tom Devaney today for further information on 091-758771 or email: CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Date Added

49 days ago