Microbiologist / Sr. Microbiologist
Microbiologist / Senior 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
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