Validation Engineer
CareerWise Recruitment
Sligo
A Validation Engineer is required by CareerWise Recruitment for our Sligo based client. THE ROLE: * Support, Maintain and improve the site validation program and ensure compliance to the quality requirements as set in the ISO 13485 and MDR. * Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate. * Strong leadership skills to bring teams along with their understanding of validation activities, including Test Method validation, Packaging validation, software, IQ, OQ, PQ and overall process validation. * Writing and reviewing protocols, reports deviations, supporting change control, and release to production after validation activities. * Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes. * Providing SME review and approval of site process and equipment validation documentation such as protocols, deviations and final reports. * Managing and coordinating validation support during the execution of the project. * Serving as the validation liaison with all vested parties including QA/QC laboratories, IT, Manufacturing, R&D, and Engineering. * To provide reports to management on validation related issues, compiling metrics to. REQUIREMENTS: * At least 3 years work experience as a Validation Engineer within Quality in medical device industry. * A level 8 degree in a Quality, Science or Engineering discipline. Please call Gillian Dunphy today for further information on 061-365969 or email: gdunphy@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the 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.
1178 days ago