Project Engineer

CareerWise Recruitment

Cork

A Project Engineer is required by CareerWise Recruitment for our Cork based medical device manufacturing client. This is an initial 12 month contract role. Please contact Diarmuid Buckley for more information. THE ROLE: * Team member representing the Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes. * Prepare several documents as part of the IQ, OQ, PQ processes. * Responsible for ensuring design of machine is aligned with operations needs, quality, EHS, validation, quality automation, maintenance requirements. * Validate the machine as per the specifications, procedures, regulations. * Determine operational & process inputs and outputs ranges of machine prior to commencing validation. * Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges. * Communicate effectively with project manager and other managers, global functions and internal team on status of project(s) tasks, issues and requirements. * Provide timely and accurate reporting and management of escalations as appropriate on project activities. * Ensure all activities comply with GMP, ISO and quality system requirements. REQUIREMENTS: * BSc in Engineering or Science with experience in a medium to high volume manufacturing environment. * 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO. * Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry preferred. * Understanding of GMP/ISO and validation regulations preferred. Please call Diarmuid Buckley today for further information on 021 -4355432 or email: dbuckley@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.

574 days ago