Senior Staff Microbiologist
Senior Staff Microbiologist
Posted on :
26-08-2025
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1 Vacancy
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Job Description
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 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:
- Bachelors 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.
#IJ
Travel Percentage: 10%Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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