Senior Staff Microbiologist

Work Flexibility: Hybrid or Onsite<p></p><p></p><p><span><b>Sr Staff Microbiologist Role, </b></span><span><b>Macroom, Cork</b></span><span><b> </b></span></p><p></p><p><span><b>Hybrid - 3-4 days onsite</b></span></p><p></p><p><span><b>Your key responsibilities:</b></span></p><ul><li><span>Define  local quality strategy to deliver safe, high-quality clean and sterile products while maintaining regulatory compliance</span></li><li><span>Oversight of Micro &amp; Sterility key processes cleaning, cleanroom, sterilization and product testing</span></li><li><span>Coach, mentor, and drive awareness to other functions in area of Micro &amp; Sterility</span></li><li><span>Subject matter expert to internal &amp; external regulatory requirements (Corporate, FDA, ISO) and local procedure owner</span></li><li><span>Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.</span></li><li><span>Review and approval Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reports</span></li><li><span>Timely communication, escalation, resolution of product issues causing supply chain disruptions</span></li><li><span>collaboration for cleaning/ sterilization/ environmental across sites in a global team across T&amp;E Franchise</span></li><li><span>Continually identifies opportunity to drive efficiencies and margin improvements</span></li><li><span>Support compliance to Micro &amp; Sterility standards in product transfers and new product introductions</span></li></ul><p></p><p><span><b>What are we looking for:</b></span></p><ul><li><span>Bachelor’s degree/ Master of Microbiology or equivalent </span></li></ul><p><span>and</span></p><ul><li><span>Minimum of 6 years relevant experience </span></li><li><span>2 years Microbiology related experience.</span></li><li><span>Experience in interacting with regulatory agencies (MDSAP, FDA, MoH, TUV, etc.) required.</span></li><li><span>Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)</span></li><li><span>Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.</span></li><li><span>Strong interpersonal skills.</span></li><li><span>Strong written and oral communication and negotiations skills.</span></li><li><span>Strong in critical thinking and "outside the box" thinking.</span></li><li><span>Highly developed problem-solving skills.</span></li><li><span>Strong analytical skills.</span></li><li><span>Demonstrated ability to successfully manage and complete projects in a matrix organization.</span></li><li><span>Demonstrated ability to work independently.</span></li><li><span>Experience in working in a compliance risk situation.</span></li><li><span>High proficiency in statistical techniques, data review and analysis.</span></li><li><span>High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.</span></li></ul><p></p><p>#IJ</p><p></p><p></p><p></p><p></p>Travel Percentage: 10%<p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p>