Microbiologist

Actalent is Hiring a Team of Microbiologists

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 accurate laboratory documentation. The position works closely with cross-functional teams to maintain robust contamination control programs, sustain inspection readiness, and uphold the highest standards of data integrity and good documentation practices.

Responsibilities

• Perform routine and non-routine environmental monitoring of clean rooms 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.

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.
• Proficiency in environmental monitoring of clean rooms 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,…