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Sterility Assurance Lead

Quality & Laboratory
Therese Keohane
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Job Reference: JO-2103-65673_1616076944


Our biotech client is looking for a Sterility Assurance Lead to join their start-up manufacturing team in Sligo. In this role you will act as SME for sterility assurance joining a talented and diverse team during this exciting phase of the project.


  • Take ownership of the site's Contamination Control Strategy
  • Work closely with the operations group to develop a training program for aseptic processing
  • Provide training in aseptic behaviours and principles to the site
  • Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
  • Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
  • Monitor and review microbiological data to detect trends
  • Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
  • Provide technical guidance on any contamination related to non-conformances or events.
  • Ensure that the site is operating under governing regulations for sterility assurance
  • Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
  • Maintain and develop site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor
  • Influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance


  • Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
  • Minimum 5 years' experience in the pharmaceutical industry or biopharma industry in a Quality/Operations role
  • Minimum 1 years' experience in an aseptic sterile fill-finish manufacturing environment
  • Minimum 1 years' experience in a microbiological function in an aseptic sterile fill-finish facility

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Therese Keohane
Therese Keohane
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