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.
- 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.
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