QC Micro – South Dublin

placeDublin calendar_month 

Desired Skills: environmental monitoring,cleanrooms,bioburden

The Role:

PE Global are recruiting for a SR QC Microbiology Associate to be based in Dun Laoghaire

12 Month initial contract – 24/7 Shift

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours. Example Shift Patter: Two days followed by Two nights: from 07:00 to 19:00 & 19:00 to 07:00.

Specific Job Duties:

  • Environmental Monitoring of Grade 8/9 Cleanrooms
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
  • Reading of Environmental Monitoring Plates
  • Bioburden testing of water & disinfectants
  • Writing technical reports
  • Water sampling
  • Testing of In Process samples such as Density & pH
Basic Qualifications
  • Bachelors degree in a science discipline
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Preferred Qualifications
  • Experience working in an aseptic cleanroom performing Environmental Monitoring
  • Proficient in the use of LIMS & LMES
Competencies
  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
  • Flexibility – the EM role often encounters changing priorities on a daily basis
  • Problem solving skills
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction
  • Work is guided by objectives of the department or assignment
  • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems
  • Demonstrated leadership and communication skills
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

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