Senior Specialist in Clean Products

2 weeks ago


Cork, Cork, Ireland beBeeMicrobiologist Full time €85,000 - €121,000
About the Role

As a senior staff microbiologist, you will be responsible for defining and implementing local quality strategies to ensure the delivery of safe, high-quality clean and sterile products while maintaining regulatory compliance.

Main Responsibilities:
  • Develop and implement quality strategies to meet regulatory requirements
  • Oversight of key processes including cleaning, cleanroom, sterilization, and product testing
  • Coach and mentor colleagues on microbiology-related topics
  • Subject matter expert on internal and external regulatory requirements
  • Analyze sampling and monitoring data to determine control and trending
  • Review and approval of cleaning/cleanroom equipment/process qualification/validation/monitorings/test reports
  • Effective communication and escalation of product issues causing supply chain disruptions

Key Performance Indicators: Quality deliverables, Regulatory compliance, Effective collaboration with global teams

Requirements:
  • Bachelor's degree/Master of Microbiology or equivalent
  • Minimum 6 years relevant experience
  • 2 years Microbiology-related experience
  • Experience interacting with regulatory agencies required
  • Strong knowledge of US and International Medical Device Regulations and standards
  • Excellent communication, project management, and influencing skills


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