QC Microbiologist (Shift)

  • Contract
  • Dublin

Website Ref:TPM04381

Summary:
A QC Microbiologist is required for a biopharmaceutical company in South Dublin. This role will support qualification of a new production facility and will include a shift pattern or extended hours. The current expectation is to work days for the initial training period, following by shift to support the facility qualification.

Responsibilities:

  • 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.
  • Utility sampling & testing.
  • Testing of In Process samples such as Protein Concentration, Density & pH.
  • Compressed gas sampling.
  • BI testing.
  • Support QC Specialist with risk assessments/procedures for new facility.
  • Working with the project team to ensure we have sufficient resources and equipment for the project.
  • Completing qualification works for the new isolator, media qualification etc.

Qualifications & Experience:

  • 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.
  • Experience working in an aseptic cleanroom performing Environmental Monitoring.
  • Proficient in the use of LIMS & LMES.
  • 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.
  • Good cross functional communication skills are essential.
  • Presentation skills.
  • 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.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.