Work Flexibility: Hybrid or Onsite

Sr Staff Microbiologist Role, Macroom, Cork

Hybrid - 3-4 days onsite

Your key responsibilities:

Define  local quality strategy to deliver safe, high-quality clean and sterile products while maintaining regulatory complianceOversight of Micro & Sterility key processes cleaning, cleanroom, sterilization and product testingCoach, mentor, and drive awareness to other functions in area of Micro & SterilitySubject matter expert to internal & external regulatory requirements (Corporate, FDA, ISO) and local procedure ownerInterpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.Review and approval Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reportsTimely communication, escalation, resolution of product issues causing supply chain disruptionscollaboration for cleaning/ sterilization/ environmental across sites in a global team across T&E FranchiseContinually identifies opportunity to drive efficiencies and margin improvementsSupport compliance to Micro & Sterility standards in product transfers and new product introductions

What are we looking for:

Bachelor’s degree/ Master of Microbiology or equivalent

and

Minimum of 6 years relevant experience 2 years Microbiology related experience.Experience in interacting with regulatory agencies (MDSAP, FDA, MoH, TUV, etc.) required.Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.Strong interpersonal skills.Strong written and oral communication and negotiations skills.Strong in critical thinking and "outside the box" thinking.Highly developed problem-solving skills.Strong analytical skills.Demonstrated ability to successfully manage and complete projects in a matrix organization.Demonstrated ability to work independently.Experience in working in a compliance risk situation.High proficiency in statistical techniques, data review and analysis.High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.

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Travel Percentage: 10%