Microbiologist

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.

Responsibilities

• Perform routine and non-routine environmental monitoring of cleanrooms and controlled areas to ensure compliance with regulatory and internal quality standards.
• Conduct testing of pharmaceutical water systems, 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) in support of sterile injectable products.
• Investigate microbial contamination events by collecting data, performing root cause analysis, and supporting the implementation of corrective and preventive actions (CAPA).
• Trend and interpret microbiological data to identify patterns, support contamination control strategies, and strengthen sterility assurance programs.
• Perform microbiological method validations and verifications, ensuring methods are suitable, robust, and compliant with applicable guidelines.
• Support equipment qualification activities for microbiology laboratory instruments, including installation, operational, and performance qualifications.
• Maintain microbiology laboratory instrumentation by coordinating and performing routine calibration, preventive maintenance, and troubleshooting to ensure reliable operation.
• Support quality systems activities such as deviations, change controls, out-of-specification (OOS) and out-of-trend (OOT) investigations, CAPAs, complaints, and quality risk assessments.
• Ensure all laboratory work complies with FDA cGMP regulations, USP and ICH guidelines, and internal procedures for aseptic processing and contamination control.
• Prepare, review, and maintain accurate laboratory documentation in accordance with ALCOA+ principles and good documentation practices to ensure data integrity.
• Collaborate closely with Quality, Manufacturing, Engineering, and Validation teams to support operational excellence, process improvements, and inspection readiness.
• Participate in or support regulatory inspections and internal or external audits by providing data, documentation, and subject matter expertise in microbiology.
• Support media preparation, plating, aseptic techniques, and sterilization activities required for microbiology laboratory operations.
• Contribute to continuous improvement initiatives to enhance microbiological control, laboratory efficiency, and overall compliance.

Requirements

• 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.
• Proficiency in environmental monitoring of cleanrooms and controlled environments.
• Experience with pharmaceutical water systems, including purified water (PW) and water for injection (WFI).
• Demonstrated ability to perform sterility testing, bioburden testing, and microbial identification.
• Hands-on experience performing bacterial endotoxin testing (BET).
• Strong understanding of FDA cGMP regulations and their application to microbiology and sterile manufacturing.
• Solid knowledge of aseptic processing, aseptic technique, and contamination control principles.
• Experience working in a microbiology laboratory, including media preparation, plating, and sterilization.
• Familiarity with environmental monitoring and microbiological testing in a cGMP setting.
• Ability to support quality systems, including CAPA, deviations, OOS/OOT investigations, change control, and quality risk management.
• Strong commitment to data integrity and good documentation practices, including adherence to ALCOA+ principles.

Qualifications

• Advanced degree in Microbiology, Biotechnology, Biological Sciences, Pharmacy, or a related scientific discipline is preferred.
• Experience supporting regulatory inspections and audits in a pharmaceutical or sterile manufacturing environment is preferred.
• Technical expertise in sterile injectable manufacturing and aseptic processing.
• In-depth knowledge of environmental monitoring and water system microbiology.
• Experience with method validation and equipment qualification for microbiological assays.
• Working knowledge of FDA cGMP, USP, and ICH guidelines relevant to microbiology and sterile products.
• Experience with quality systems such as CAPA management, deviation handling, OOS/OOT investigations, change control, and quality risk management (QRM).
• Strong analytical and problem-solving skills to support contamination investigations and continuous improvement.
• Effective communication and collaboration skills to work with cross-functional teams.

Work Environment

The role operates in a cGMP-regulated sterile injectable pharmaceutical manufacturing environment, including microbiology laboratories and clean room areas. Work is performed in controlled environments that follow strict aseptic techniques, environmental monitoring programs, and contamination control procedures. The position involves routine work with microbiological media, plating, sterilization processes, and testing of water systems and sterile products.

Standard working hours are generally 8:30 a.m. to 5:00 p.m., with the flexibility to adjust hours if operational demands change. Personnel follow cleanroom gowning procedures and adhere to all applicable safety, cleanliness, and compliance requirements while working in GMP facilities.

Pay

The pay range for this position is $40.87 - $55.29/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a Contract to Hire position based out of Boca Raton, FL. The role is fully onsite.