Senior SterilISAtion Engineer

Careerwise Recruitment

Galway

A Senior Sterilisation Engineer is required by CareerWise Recruitment for our Galway based client. Works with Product Development Teams and or external customers to plan and execute Sterilisation Validation Activities. Supports key sterilisation programs such as sterile load process review and revalidation activities. Responsible to monitor and implement changes to respective programs as improvements or updates are identified.Please contact Tom Devaney for more information. THE ROLE: * Creation and approval of Sterilisation Validation Protocols and Reports. * Review and Approval of test results and associated test method validations. * Collaboratively works with external contract sterilisation test facility. * Assess/Coordinate cycle consolidation opportunities. * Support Design Service Project Teams with respect to validation of product in approved cycles. * Management of process deviations, NCRs and CAPAs related to Sterilisation Processes. * Support Design Service Project Teams with ancillary Sterilisation activities such as test unit preparation and dunnage management. * Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to sterilisation. * Responsible for maintenance of site Sterilisation procedures. * Conduct supplier auditing as required. REQUIREMENTS: * Higher Education Qualification in science/engineering. * 3 years of demonstrated experience in the medical device or pharmaceutical industry with experience specific to ethylene oxide sterilization cycle development and maintenance. * Knowledge of medical device products and regulations. * Experience in industrial ethlene oxide sterilization; including microbial inactivation kinetics. * Microbiological experience in environmental monitoring, and laboratory procedures preferred. * Auditing experience. * Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO. * Demonstrated decision making skills and effective problem solving abilities. * Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities. * Knowledge of Microbiological and Environmental monitoring programs preferred. * Proficient in the following computer software applications: Microsoft Office. * Exceptional interpersonal skills. * Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. * Technical Writing skills. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. 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. This job originally appeared on RecruitIreland.com.

1830 days ago