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Quality Engineer - Microbiologist

Job Title: Quality Engineer - Microbiologist
Contract Type: Contract
Location: Cork
REF: 86292
Job Published: over 1 year ago

Job Description

Quality Engineer - Microbiologist

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

Essential Requirements
  • 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 /
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