Bachelor’s, Master’s, or Ph.D. degree in Microbiology, Biology, or a related field
Ideally a minimum of 2 years of experience in a pharmaceutical or biotechnology microbiology laboratory
Experience with aseptic techniques, environmental monitoring, and microbiological method development is preferred
Proficiency in microbiological techniques, including sterility testing, endotoxin testing, microbial identification, and antimicrobial effectiveness testing
Familiarity with laboratory equipment such as autoclaves, incubators, and biosafety cabinets
Understanding of regulatory requirements and guidelines (e.g., FDA, E)
Responsibilities
Perform routine and non-routine microbiological testing of raw materials, in-process samples, finished products, and environmental samples in compliance with regulatory standards (e.g., USP, EP, JP)
Implement and oversee environmental monitoring programs to ensure the aseptic conditions and sterility of manufacturing environments, including air, surface, water, and personnel monitoring
Develop, validate, and optimize microbiological methods for the detection, enumeration, and identification of microorganisms, ensuring compliance with regulatory guidelines and industry best practices
Perform quality control checks on media, reagents, and equipment to ensure accurate and reliable test results; participate in investigations of out-of-specification results and implement corrective actions
Maintain accurate and detailed records of all microbiological testing activities; prepare technical reports, Standard Operating Procedures (SOPs), and other documents as required
Ensure adherence to all regulatory and safety protocols, including Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP); participate in internal and external audits and inspections
Work collaboratively with cross-functional teams, including Quality Assurance, Engineering, and Manufacturing, to support product development, process improvements, and troubleshooting activities
Train and mentor Microbiology Lab assistants, manufacturing operators, and engineers in the fundamentals of Microbiology and working within a cleanroom
Promote a culture of continuous learning and improvement within the microbiology team
Undertake additional tasks and responsibilities as assigned by the line manager to support evolving team and organizational needs
Provide regular updates on Pharmaceutical Quality system status, risk assessments, and quality metrics through detailed reports and presentations
Embed quality processes into the routine manufacturing processes at Ecolab Baglan