Lead Microbiologist - GMP Cleanroom Specialist
About the Role
We are seeking an experienced microbiologist to lead our Environmental Monitoring (EM) program and provide 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 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
About You
* 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)
Benefits
* 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