QC Microbiologist (Shift)

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.