Microbiologist I

• Report directly to the Site Microbiologist and support the delivery of key Quality, Compliance, and Performance objectives. 

• Ensure ongoing compliance with cGMP requirements and applicable regulatory standards, including those of the FDA, TÜV, DEKRA, and other relevant regulatory agencies. 

• Provide microbiological expertise and guidance to cross-functional teams on topics including regulatory requirements, product bioburden, endotoxin control, contamination control, and microbiological impacts of product or process changes. 

• Coordinate and support training activities for Laboratory Analysts, promoting a strong culture of quality, compliance, and continuous development. 

• Ensure compliance with all laboratory procedures, quality system requirements, and relevant site-wide policies and practices. 

• Lead the introduction of new laboratory equipment, including coordination of qualification activities, change control implementation, and associated documentation. 

• Prepare for and participate in internal, customer, and regulatory audits, serving as a Subject Matter Expert (SME) for microbiology-related activities. 

• Conduct daily review of microbiological testing raw data to ensure prompt identification, investigation, and closure of laboratory records, deviations, and related documentation within defined timelines. 

• Author, revise, review, and approve Standard Operating Procedures (SOPs), laboratory methods, protocols, reports, and other quality documents as required. 

• Coordinate microbiological validation activities for new products in collaboration with New Product Introduction (NPI) teams to ensure successful implementation with minimal impact to routine commercial testing. 

• Provide technical leadership and mentorship to Technician I and Technician II personnel while fostering a safe and compliant laboratory environment. 

• Attend and represent the Microbiology function at cross-functional meetings, project teams, and site initiatives. 

• Support the Site Microbiologist in ensuring a cost-effective, efficient, and responsive microbiology testing service. 

• Schedule laboratory testing activities and, in the absence of the Site Microbiologist, oversee the day-to-day operation and management of laboratory activities. 

• Drive continuous improvement activities that enhance laboratory efficiency, compliance, data integrity, and overall operational effectiveness. 

• Complete, review, and approve microbiological and laboratory-related non-conformances, deviations, and CAPAs, ensuring timely closure and compliance with site Quality System requirements. 

• Minimum 3 years' relevant experience in a GMP-regulated microbiology laboratory, preferably within the medical device, pharmaceutical, or biotechnology industry. 

• Degree in Microbiology, Biological Sciences, Biomedical Sciences, or a related scientific discipline. 

• Experience working in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. 

• Knowledge of microbiological testing methods including bioburden, endotoxin, environmental monitoring, and contamination control. 

• Understanding of cGMP requirements and medical device regulatory expectations. 

• Strong technical writing, problem-solving, and organizational skills. 

• Ability to lead projects, manage multiple priorities, and work effectively within cross-functional teams. 

• Excellent communication and interpersonal skills. 

Core Competencies:

• Technical Expertise in Microbiology 

• Regulatory Compliance & Quality Systems 

• Data Review and Documentation Management 

• Leadership and Mentoring 

• Project Management 

• Continuous Improvement 

• Audit Readiness & Inspection Support 

• Problem Solving and Risk Assessment 

• Collaboration and Stakeholder Engagement