Microbiologist

Job Title: Microbiologist / Sr Microbiologist Job Description This role supports microbiological testing and environmental monitoring activities within a sterile injectable pharmaceutical manufacturing environment. The Microbiologist / Sr 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.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). Additional Skills & 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 biotechnology environment is preferred.Technical expertise in sterile injectable manufacturing processes.Experience with aseptic processing and advanced contamination control programs.Knowledge of environmental monitoring and water system design and control strategies.Experience with sterility, bioburden, and endotoxin testing method validation and verification.Hands-on involvement in equipment qualification for microbiology laboratory instruments.Working knowledge of FDA cGMP, USP, and ICH guidelines relevant to microbiology and sterile manufacturing.Experience with data trending and analysis to support sterility assurance and contamination control initiatives.Strong collaboration skills with cross-functional teams, including Quality, Manufacturing, Engineering, and Validation. 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 identification, and endotoxin testing. You follow strict cGMP, data integrity, and good documentation practices in all activities, contributing to a culture of quality, compliance, and continuous improvement. Job Type & Location This is a Contract to Hire position based out of Boca Raton, FL. Pay And Benefits The pay range for this position is $40.87 - $55.29/hr. 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) Workplace Type This is a fully onsite position in Boca Raton,FL. Application Deadline This position is anticipated to close on Aug 14, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.