Expert Contamination Control Specialist

3 days ago

Melbourne, Victoria, Australia beBeeMicrobiologist Full time
Senior QC Microbiologist Role

Join a newly built, state-of-the-art cGMP facility as a Senior Quality Control (QC) Microbiologist. You will play a critical role in shaping the foundation of our clinical manufacturing site and contribute to accelerating medical breakthroughs safely and compliantly.

  • Develop and oversee the Environmental Monitoring (EM) program to ensure contamination control strategies are effective.
  • Manage sampling, testing, and release of raw materials and utilities, ensuring compliance with regulatory requirements.
  • Interpret test data, identify trends, and lead investigations into excursions or deviations to maintain product quality.
  • Develop microbiological Standard Operating Procedures (SOPs), validation protocols, and quality documentation to support cleanroom qualification, aseptic practices, and contamination risk mitigation strategies.
Required Skills and Qualifications:
  • Bachelor's degree in Microbiology (postgraduate degree preferred).
  • 5+ years' experience in a QC Microbiology role within a regulated cGMP environment.
  • Strong knowledge of microbiological testing methods, cleanroom EM practices, and raw material/utility release.
  • Hands-on experience in method development, deviation investigations, and technical training.
  • Excellent interpersonal and communication skills, with a collaborative and proactive mindset.
  • Proven ability to manage documentation, risk assessments, and regulatory compliance (TGA/FDA/ISO).
Key Benefits:
  • Be part of an Australian-first biomedical manufacturing facility.
  • Collaborate with a network of high-impact MedTech and Biotech companies.
  • Shape and implement contamination control systems from the ground up.
  • Enjoy a dynamic role at the interface of science, technology, and clinical innovation.
  • Work in a flexible, purpose-driven environment where your expertise makes a real impact.

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