Microbiologist / Sr. Microbiologist

EPM Scientific; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

EPM Scientific in Boca Raton, FL is seeking a Microbiologist / Senior Microbiologist to support microbiology operations within a sterile manufacturing environment. The role focuses on maintaining product quality, contamination control, environmental monitoring programs, and microbiological testing while ensuring cGMP compliance and regulatory readiness.

Collaboration across Quality, Manufacturing, and Validation teams is essential.

Qualifications

• BS degree in Microbiology or related field.
• 5+ years in pharmaceutical microbiology.
• Experience supporting sterile manufacturing operations.
• Hands-on environmental monitoring and microbiological testing.
• Knowledge of cGMP and quality systems.
• Strong investigative and documentation skills.

Responsibilities

• Perform environmental monitoring in manufacturing areas.
• Support contamination control and sterility assurance programs.
• Monitor environmental trends and excursions.
• Assist with contamination investigations and CAPAs.
• Conduct sterility, bioburden, endotoxin, and microbial testing.
• Maintain laboratory records and documentation.
• Collaborate with Quality, Manufacturing, Validation and Engineering teams.

Skills

Environmental monitoring

Sterile manufacturing

Microbiology testing

Investigation & documentation

Education

BS in Microbiology or related field

Tools

Environmental monitoring equipment

Job description

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
• 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 Scientist

Sterility Assurance 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