Temp Cip/Sip Validation Specialist
TEMP CIP/SIP VALIDATION SPECIALIST required by CareerWise Recruitment for a maternity cover contract for 6 months approx. with our BioTech client in Limerick. The TEMP CIP/SIP VALIDATION SPECIALIST will require cleaning or steaming experience and project management experience. THE ROLE: * Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. * Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. * SIP thermocouple placement for steam sterilisation and steam sanitization. * Analyzes 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. * Specifically focused on the SIP Validation activities, to support the QA Validation Lead in that area. * Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. * Reviews, edits and approves change control and SOPs. * Coordinates with other departments or outside contractors/vendors to complete validation tasks. * Reviews, edits and approves reports, such as automation performance evaluation reports, and other reports or documentation submitted to the department. * Trains less experienced Specialists and Technicians. * Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs. * Manages projects and prepares status reports. * Generation of KAYE reports. 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 and usage of KAYE validator software is an advantage. Please call Conor Twomey today for further information on 021-4297422 or email: firstname.lastname@example.org. 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 Irelands 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. This job originally appeared on RecruitIreland.com.
160 days ago