Microbiologist / Sr. Microbiologist

Boca Raton, FL | Onsite
Sterile Pharmaceutical Manufacturing
Full-Time

A growing pharmaceutical manufacturing organization is seeking a Microbiologist / Senior Microbiologist to support microbiology operations within a sterile manufacturing environment.

This role will play a key part in maintaining product quality, contamination control, environmental monitoring programs, and microbiological testing activities while supporting compliance with cGMP and regulatory requirements.

Key Responsibilities

Environmental Monitoring & Sterility Assurance

• Perform and support environmental monitoring activities within manufacturing areas
• Support contamination control and sterility assurance programs
• Monitor and evaluate environmental trends and excursions
• Assist with contamination investigations and corrective actions

Microbiology Testing

• Conduct sterility, bioburden, endotoxin, and microbial testing activities
• Perform microbial identification and trend analysis
• Support water system monitoring and utility testing programs
• Maintain accurate laboratory records and documentation

Investigations & Compliance

• Support investigations related to environmental excursions, OOS results, and microbiological events
• Assist with CAPAs, deviations, and change control activities
• Ensure compliance with cGMP requirements and internal quality standards
• Maintain inspection readiness and support audit activities

Method Validation & Laboratory Support

• 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

Ideal Background

• Microbiologist

• Senior Microbiologist

• QC Microbiology Specialist

• QC Microbiology Scientist

• Sterility Assurance Specialist

• Environmental Monitoring Specialist

• Experience within sterile pharmaceutical manufacturing environments

• Strong understanding of contamination control and microbiological testing

• Comfortable working cross-functionally in a manufacturing setting

• Experience supporting audits, inspections, and GMP compliance initiatives