Senior Validation Engineer

CAREERWISE RECRUITMENT

CORK

A Senior Validation Engineer is required by CareerWise Recruitment for our Cork based med device client This is a 12 month initial contract role to support major Manufacturing Engineering Projects . Please contact Diarmuid Buckley for full details. THE ROLE: * Competent in Validation requirements on new processes/ equipment introductions & process changes. * Process Validation for the transfer of processes within the facility. * Defines the requirements for Process Validation studies in alignment with approved SOPs. * Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages. * Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements. * May also investigate and trouble-shoot problems which occur and determine solutions. * Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. * Maintains and archives all documentation pertaining to validation. * Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups. * As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies. * Independently applies validation principles to work assignments, reviews and approves documents and resolves problems. * Coordinates assigned projects and represents department on project teams. REQUIREMENTS: * Degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience. * Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations. * Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Ireland's leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

1689 days ago