Senior Microbiologist

Key Responsibilities:

• Perform quality sampling for clean utilities systems such as Purified Water, Water for Injection and Pure Steam
• Perform environmental monitoring for classified cleanrooms, clean air devices and personnel monitoring
• Conduct various microbiological, and analytical tests and physical test, including, Bioburden Tests, Bacterial Endotoxin Tests, Sterility Tests, Conductivity Tests, Total Organic Carbon Tests, and Container Closure Integrity Testing for raw materials, packaging components, in-process samples, drug substances and drug products
• Perform quality control release tests for microbiology such as GPT, and BI
• Support environmental monitoring risk-based assessment (EMRA)
• Perform processing of biological indicators for manufacturing equipment validation/re-validation
• Participate in Aseptic Process Simulation
• Manage inventories required for microbiological sampling and testing
• Developing, validating and/or method suitability for microbiological testing methods
• Analyzing, interpreting, and maintaining accurate documentation for microbiological results
• Perform periodic review of microbiological data and laboratory documents
• Perform/support qualification of laboratory instrument and Controlled Temperature Unit
• Perform/support laboratory instrument calibration and preventative maintenance
• Lead/support Continuous Improvement initiatives
• Lead/support out-of-specification, lab investigations, deviations and implementing corrective actions.
• Lead/support site audits/regulatory inspections on site

Qualifications:

• Bachelor's degree or higher in biological sciences, biotechnology, pharmaceutical sciences or equivalent with min 5 years of working experience
• Prior experience in working in a GMP laboratory preferred
• In-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.
• Proficiency in English as a working language.