Our client, a large manufacturing company in Cork requires a skilled Microbiologist to work with the primary objective to ensure customer satisfaction by monitoring, controlling and improving cleanroom related customer processes. The candidate will need have a degree in Science preferably Biotechnology, Microbiology or Biochemistry,
- Principal customer interface for Cleanroom performance and biological, steralisation, bioburden and endotoxin results.
- Quality metrics and improvement initiatives.
- Set up a biological testing lab so that timely viable testing can be performed on site in addition to non-viable testing.
- Set up and validate a 'bubble and burst' test facility in conjunction with our customer so that machine performance can be verified in a timely manner.
- Provide leadership in the area of cleanroom performance and biological testing and to the Quality Technicians in the area.
- Management of the Quality Technicians and Operational quality support for the Cleanrooms.
- Generation of key performance controls as part of Quality Metrics System.
- Data collection, analyzing and reporting.
- Initiate and drive Continuous Improvement programs.
- CAPA, NCM and RMA analysis and Improvement and QSR Validation protocols and report (IQ, OQ & PQ).
- Conducting Audits to ensure conformance and effectiveness of the Quality System.
- Other duties from time to time as required by the Quality Engineering supervisor or Quality Manager
- Degree in Science preferably Biotechnology, Microbiology or Biochemistry,
- At least 2-3 years Quality Assurance / Regulatory affairs experience. In a similar Quality Engineering role in the medical devices / Electronics or Pharmaceutical/ industry.
- Knowledge of Biological Excursions plus Endotoxin and Bioburden Results, and Close Control and management of Cleanroom biological performance,
- Sound understanding and utilization of Problem Solving Techniques
- Proficient in the use of Microsoft Word, Power-point and Excel.
- Good Communications, Supervisory and influencing skills.
- Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
- Ability to write standard operating procedures, training documents, and regulatory responses.
- Experience in Cleanrooms, Steralisation ( EtO, E-beam etc) and Microbiology
- Cleanroom (Class 8) Experience
For further information on this Microbiologist role in Cork please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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