Senior Microbiologist & Cleanroom Compliance Lead

FITS LLC; Dorado (PR); On-site; USD 120,000 - 150,000; Full time

Job summary

FITS LLC in Dorado, Puerto Rico, is seeking a Senior Microbiologist Specialist to lead and execute complex microbiological investigations, write protocols, and ensure GMP-compliant environmental monitoring within ISO Class 8 cleanrooms.

The role emphasizes CAPA-driven problem solving, regulatory alignment with FDA, ISO 14644/13485/11737, and mentorship of laboratory personnel to uphold top-tier quality in pharmaceutical and medical device manufacturing.

Qualifications

• Bachelor's degree in Microbiology or related field; 10+ years in regulated pharma/medical device testing.
• Experience in ISO Class 8 cleanrooms and environmental monitoring.
• Strong investigation and CAPA experience with regulatory alignment.

Responsibilities

• Lead and support investigations (OOS, environmental excursions, adverse trending).
• Write protocols and reports (Qualifications and Re-qualifications, e.g. Clean Rooms & Equipment).
• Create / Revise Laboratory procedures.
• Prepare and approve technical reports documenting investigation findings, qualification activities, and corrective actions.
• Monitor and evaluate environmental monitoring programs, including air sampling, surface monitoring, bioburden testing, and BET.
• Analyze microbiological and environmental data to identify trends, assess risks, and recommend CAPAs.
• Create, revise, and maintain microbiology lab procedures, SOPs, and testing methodologies.
• Serve as SME for microbiological compliance and contamination control in ISO Class 8 environments.
• Ensure FDA regulations and ISO standards compliance (ISO 14644, 13485, 11737).
• Provide technical guidance and mentorship to laboratory personnel.
• Support internal audits, regulatory inspections, and quality system initiatives.

Skills

Investigation leadership

Environmental monitoring

CAPA implementation

SOP development

GxP knowledge

Education

Bachelor's degree in Microbiology or related field

Tools

BET

Bioburden testing

Air sampling

Environmental monitoring systems

Job description

FITS LLC in Dorado, Puerto Rico, is seeking a Senior Microbiologist Specialist to lead and execute complex microbiological investigations, write protocols, and ensure GMP-compliant environmental monitoring within ISO Class 8 cleanrooms.

The role emphasizes CAPA-driven problem solving, regulatory alignment with FDA, ISO 14644/13485/11737, and mentorship of laboratory personnel to uphold top-tier quality in pharmaceutical and medical device manufacturing.