Job Description

This role supports microbiological testing and environmental monitoring activities within a sterile injectable pharmaceutical manufacturing environment. The Microbiologist ensures product quality, sterility assurance, and compliance with FDA cGMP regulations by performing environmental monitoring, water system testing, sterility testing, microbial identification, contamination investigations, and comprehensive laboratory documentation.

Responsibilities

• Perform routine and specialized environmental monitoring in cleanrooms and controlled areas to ensure compliance with regulatory and internal quality standards.
• Conduct water system testing, including purified water (PW) and water for injection (WFI), to verify microbiological quality and system control.
• Execute sterility testing, bioburden testing, microbial identification, and bacterial endotoxin testing (BET) to support release and validation activities.
• Investigate microbial contamination events, participate in root cause analysis, and support the development and implementation of corrective and preventive actions (CAPA).
• Trend and interpret microbiological data to support contamination control and sterility assurance programs and recommend improvements where needed.
• Perform microbiological method validations and verifications, ensuring methods are robust, reliable, and compliant with applicable guidelines.
• Support equipment qualification activities for microbiology laboratory instruments, including installation, operational, and performance qualifications.
• Maintain microbiology laboratory instrumentation, ensuring proper calibration, preventive maintenance, and adherence to compliance requirements.
• Support quality systems activities, including deviations, change controls, out-of-specification (OOS) investigations, out-of-trend (OOT) assessments, CAPAs, complaints, and quality risk management (QRM).
• Ensure accurate and complete laboratory documentation, following ALCOA+ data integrity principles and good documentation practices.
• Collaborate closely with Quality, Manufacturing, Engineering, and Validation teams to support operational excellence and inspection readiness.
• Support regulatory inspections and internal or external audits by providing microbiology expertise, documentation, and responses to queries.
• Apply aseptic techniques, plating, media preparation, and sterilization practices in daily laboratory operations to maintain a controlled microbiological environment.

Essential Skills

• Bachelor's degree in Microbiology, Biotechnology, Biological Sciences, Pharmacy, or a related scientific discipline.
• 5+ years of pharmaceutical microbiology experience.
• Hands-on experience working within a sterile injectable pharmaceutical manufacturing environment.
• Experience supporting regulatory inspections and audits in a pharmaceutical or biotechnology environment is preferred.
• Technical expertise in sterile injectable manufacturing processes.
• Practical experience with environmental monitoring (EM) in GMP cleanrooms and controlled environments.
• Hands-on experience with water systems, including purified water (PW) and water for injection (WFI) microbiological testing.
• Proficiency in sterility testing, including execution, documentation, and interpretation of results.
• Experience performing microbial identification using appropriate laboratory techniques and systems.
• Hands-on experience with bacterial endotoxin testing (BET).
• Strong understanding of FDA cGMP regulations and their application to microbiology and sterile manufacturing.
• Solid knowledge of aseptic processing principles and contamination control strategies.
• Demonstrated ability to apply aseptic technique in microbiology laboratory and cleanroom settings.
• Experience with microbiology laboratory practices, including plating, media preparation, and sterilization.
• Working knowledge of data integrity principles (ALCOA+) and good documentation practices.
• Familiarity with quality systems, including CAPA, deviations, OOS/OOT investigations, change control, and quality risk management (QRM).

Work Environment

The role operates within a GMP-regulated cleanroom and microbiology laboratory environment, supporting sterile injectable pharmaceutical manufacturing. You work in controlled areas that require adherence to cleanroom protocols and aseptic techniques. The position involves routine work with environmental monitoring equipment, water system sampling points, and microbiology laboratory instruments used for sterility, bioburden, microbial ident