Microbiologist / Sr. Microbiologist

Key Responsibilities

• Perform and support environmental monitoring activities within manufacturing areas
• Support contamination control and sterility assurance programs
• Monitor and evaluate environmental trends and excursions
• Afford assistance with contamination investigations and corrective actions
• Conduct sterility, bioburden, endotoxin, and microbial testing activities
• Perform microbial identification and trend analysis
• Sustain accurate laboratory records and documentation
• Support water system monitoring and utility testing programs
• Support investigations related to environmental excursions, OOS results, and microbiological events
• Afford assistance with CAPAs, deviations, and change control activities
• Ensure compliance with cGMP requirements and internal quality standards
• Maintain inspection readiness and support audit activities
• Assist with method validation and method verification activities
• Support laboratory equipment qualification and maintenance activities
• Participate in continuous improvement initiatives across quality and microbiology operations
• Partner with Quality, Manufacturing, Validation, and Engineering teams

Qualifications

• BS degree in Microbiology, Biology, Biotechnology, Life Sciences, or related scientific discipline
• 5+ years of experience within pharmaceutical microbiology
• Experience supporting sterile manufacturing operations
• Hands-on experience with environmental monitoring and microbiological testing
• Knowledge of cGMP regulations and microbiology laboratory practices
• Strong investigation, documentation, and communication skills