Senior Staff Microbiologist

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 compliance
• Oversight of Micro & Sterility key processes cleaning, cleanroom, sterilization and product testing
• Coach, mentor, and drive awareness to other functions in area of Micro & Sterility
• Subject matter expert to internal & external regulatory requirements (Corporate, FDA, ISO) and local procedure owner
• Interpreting 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 reports
• Timely communication, escalation, resolution of product issues causing supply chain disruptions
• collaboration for cleaning/ sterilization/ environmental across sites in a global team across T&E Franchise
• Continually identifies opportunity to drive efficiencies and margin improvements
• Support 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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