Senior Microbiologist
Core
Provides technical leadership and oversight of microbiological control, environmental monitoring, and sterility assurance programs to support the manufacture of safe, compliant, and high-quality medical devices.
Role type
Senior Microbiologist (Site Subject Matter Expert)
Builds
Safe, compliant, and high-quality medical device products
Domain
Medical device manufacturing / GMP / Sterility Assurance
Required skills
Microbiology, Contamination control, Environmental monitoring, Sterility assurance, Validation activities, Risk assessment, Regulatory compliance (TGA/GMP/ISO), Data trend analysis, Investigation leadership, Technical documentation
Preferred skills
Commercial awareness, Operational problem solving, Audit support, Continuous improvement
Technologies
ISO 13485, ISO 14644, ISO 11737, GMP, TGA
Responsibilities
Lead microbiological investigations and validation activities; Monitor and trend microbiological and cleanroom data; Oversee external microbiology laboratories; Develop and maintain microbiology procedures and protocols; Partner with Quality, Manufacturing, and Regulatory teams for audits.
Seniority
Senior, hands-on IC