CSV Engineer
CAREERWISE RECRUITMENT
LIMERICK
Excellent opportunity for a Computer Systems Validation Engineer / Principal QA Validation Specialist. This is a permanent opportunity with a top multinational in Limerick. Attractive salary and full benefits package on offer for the right person. The successful cadidate will validate/qualify site computerised systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. THE ROLE: * Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. * Analyses the results of testing and determines the acceptability of results against pre-determined criteria. * Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. * Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. * Reviews, edits and approves change controls, SOPs, reports and other documentation. * Coordinates with other departments or outside contractors/vendors to complete validation tasks. * Collaborates with functional departments to resolve issues. Trains/advises less experienced Specialists. * Manage and drives projects and prepares status reports. * May manage full time employees and/or contingent workers and supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines. REQUIREMENTS: * BS/BA in Engineering, Chemistry, or Life Sciences with 3 years of related experience within the field preferred; may substitute relevant experience for education. * Experience with qualification of IT Enterprise systems or MES PAS-X highly desirable. * Experience of implementing systems in accordance with 21CFR Part 11 regulations i.e. Electronic Sigs & Electronic Records which also leads on to data Integrity & Audit Trail review. * Project management experience will be an advantage. Please call Michelle Galvin today for further information on 091 373 938 or email: mgalvin@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.
1364 days ago