Microbiologist I

• Report directly to the Site Microbiologist and support the delivery of key Quality Compliance and Performanceobjectives.

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

• Provide microbiologicalexpertiseand 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 andparticipatein 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 asrequired.

• 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 ensuringtimelyclosure 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