
Senior QC Microbiologist
2 weeks ago
Join to apply for the Senior QC Microbiologist role at KE Select
3 days ago Be among the first 25 applicants
Join to apply for the Senior QC Microbiologist role at KE Select
Get AI-powered advice on this job and more exclusive features.
About the Company Are you ready to take your microbiology expertise to the next level in a cutting-edge biomedical manufacturing environment? Join a newly built, first-of-its-kind GMP cleanroom-on-demand facility designed to support Australia's most innovative MedTech and Biotech ventures.
This role offers a unique opportunity to help shape the foundation of a purpose-built clinical manufacturing site, supporting the development of life-changing therapies, diagnostics, and medical technologies. You'll be part of a collaborative, future-focused team committed to accelerating medical breakthroughs safely and compliantly.
About the Role As Senior QC Microbiologist, you will take ownership of the Environmental Monitoring (EM) program and lead the quality oversight of raw material and utility release in a state-of-the-art cGMP facility.
You will play a critical role in both the start-up and operational phases, contributing to contamination control strategies, cleanroom validations, and technical support for on-site innovators and manufacturing teams.
Key Responsibilities Include
- Develop and oversee the Environmental Monitoring (EM) program
- Manage sampling, testing, and release of raw materials and utilities
- Interpret test data, identify trends, and lead investigations into excursions or deviations
- Develop microbiological SOPs, validation protocols, and quality documentation
- Support cleanroom qualification, aseptic practices, and contamination risk mitigation strategies
- Provide subject matter expertise to stakeholders and regulatory bodies during inspections and audits
- Lead and support continuous improvement in microbiological quality processes
- Bachelor's degree in Microbiology (postgrad a plus)
- 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)
- Be a key player in 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
Apply now and become a core part of a bold initiative supporting the next generation of life-saving medical solutions. This is your opportunity to lead, influence and grow – all while helping bring breakthrough science to life. This is a Brisbane site based position. Candidates who are looking to relocate from interstate are encouraged to apply.
For a confidential discussion, please contact Ruby on 0481200171 or ruby@keselect.com.Seniority level
- Seniority levelMid-Senior level
- Employment typeFull-time
- Job functionResearch, Analyst, and Information Technology
- IndustriesHuman Resources Services
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