Senior Staff Microbiologist

Work Flexibility: Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>12 month fixed term contract - onsite in Carrigtwohill</b></p><p></p><p><b><span>Who we want:</span></b></p><ul><li><span>Meticulous documenters.</span> Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.</li><li><span>Self-directed initiators.</span> People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.</li></ul><p></p><p><b>What you will do: </b></p><p></p><ul><li>Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards. </li><li>Monitoring of utilities including all grades of water, and where necessary, compressed air. </li><li>Co-ordination of samples for bioburden and endotoxin testing. </li><li>Ordering consumables (media etc) and general stock for day-to-day running of laboratory. </li><li>Applying cGLP to all laboratory activities including stock control. </li><li>Performing sampling for validations and re-qualifications as required. Review of validation files for compliance. </li><li>Strong interactions, maintenance and support of sterility suppliers. </li><li>Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending. </li><li>Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis. </li><li>Performs sterility release review, interpreting data and trends. </li><li>Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. </li><li>Mentors and trains team and cross functional groups as required (induction, GMP etc) </li><li>Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.</li><li>Coach, mentor and train other functions in area of sterility and monitoring. </li></ul><p></p><p></p><p><b>What are we looking for: </b></p><ul><li>Bachelor’s degree/ Master of Microbiology or equivalent </li><li>Minimum of 6 years in Quality/Regulatory Affairs environment or  6 years Microbiology related experience. </li><li>Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. </li><li>Must possess effective communication, project management and influencing skills as well as have the ability to manage multiple tasks <span>simultaneously. </span></li><li>Strong interpersonal skills. </li><li>Strong written and oral communication and negotiations skills. </li><li>Strong in critical thinking and &#34;outside the box&#34; thinking. </li><li>Highly developed problem-solving skills. </li><li>Strong analytical skills. </li><li>Demonstrated ability to successfully manage and complete projects in a matrix organization. </li><li>Demonstrated ability to work independently. </li><li>Experience in working in a compliance risk situation. </li><li>High proficiency in statistical techniques, data review and analysis. </li></ul><p></p><p><b>Desirable: </b></p><p><span>Gamma and Ethylene Oxide sterilization</span> experience</p><p></p><p>#IJ</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>