Laboratory Lead - Kilkenny

Laboratory Lead - Kilkenny

hays plc | Kilkenny, IE

Posted 15 days ago

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Exciting opportunity to join this start-up medical device manufacturing facility in Kilkenny. As Laboratory Lead - you will be part of an experienced team designing and setting up a new microbiology and sterilization dose laboratory. Role Plan, organize, staff, train, direct and control the activities for the Microbiology and dose laboratories. Develop and issue goals, policies, procedures and programs to produce results . Determine requirements for new and replacement tools, providing training and job instruction, knowing safety rules and regulations and making sure all personal are trained on safe work practices. Provide expert technical support to direct reports for areas of responsibility. Assure that all regulatory requirements are met and maintained to include FDA, GMP, and ISO requirements. Coordinate internal and external microbiology and dosimetry testing to ensure accuracy of data and timely communication of results. Maintain the organization of the labs, custodian of calibrated instruments, maintaining inventory of supplies, storage and maintenance of test fixtures, and the contact person for released test instructions and training. Adhere to general safety rules, manufacturing procedures, company policies and procedures, Good Manufacturing Practices and FDA regulations. Share responsibility for all aspects of Quality and Regulatory Compliance Provide Facility Microbiological Support. Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods. Run the Data analysis of sterilization processes. Direct microbiologists and dosimetry analysts to write protocols and reports for qualifications for sterilization, dosimetry, cleanroom and microbiological test method and equipment validations and provides guidance and feedback. Requirements Relevant third level qualification. Engineering/Manufacturing/Science is preferred. Min 5 years in the Scientific/Engineering/Manufacturing field. Experience with ISO 8 cleanrooms, radiation sterilisation, dosimetry, bioburden testing and endotoxin testing is preferred. Previous experience developing projects or sites from square one, would be preferred.