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Senior Microbiologist

Job description

Purpose

This exciting new Senior Microbiologist role will lead and implement all microbiological services to maintain and meet all requirements for aseptic processing and filling of ACDs.

This job will involve a hand in setting up the brand new lab therefore experience in a similar start up environment will be advantageous.

 

Requirements

  • Bachelor Degree qualification in Biology or Microbiology (Masters qualification would be preferable)
  • A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines
  • 3 -5 years’ (minimum) experience in microbiology is a requirement
  • Working in a sterile/aseptic/pharma environment is a distinct advantage
  • Experience in supporting regulatory inspections HPRA, FDA etc is an advantage
  • Experience in cleaning validation is an advantage

 

Responsibilities

 

  • Design & Set-up of new Microbiological Laboratory
  • Validation and Qualification of equipment
  • Vendor and stakeholder engagement
  • Develop Microbiological Laboratory procedures
  • Overview the Environmental Monitoring process and personnel hygiene process
  • Responsible for execution of media fill runs
  • Responsible for Microbiological testing of finish product
  • Responsible for Microbiological monitoring of utilities
  • Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements
  • Carry out environmental and material microbiological tests as required.
  • Define and update procedures for plant relative to microbiological and environmental monitoring
  • Establish & Train laboratory staff in operational tests
  • Test method transfer of microbiological method

 

To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: areynolds@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent