Microbiologist

Job Title: Microbiologist

Job Description

This role performs a wide range of microbiological assays and environmental monitoring activities to support clinical and commercial manufacturing. The microbiologist conducts qualitative, quantitative, and investigational testing on raw materials, in-process samples, finished products, components, and facility utilities in compliance with USP, FDA, cGMP, GLP, and internal standard operating procedures. The position involves interpreting results against specifications, documenting findings, supporting investigations and CAPA activities, and may include guiding and training junior staff members.

Responsibilities

• Perform microbiological assays on facility water systems, in-process and finished products, filling components, raw materials, and environmental monitoring samples.
• Execute microbial bioburden testing of water systems, in-process and finished products, containers, components, and environmental samples.
• Perform endotoxin testing via Kinetic Turbidimetric Assay and Gel Clot methods on water systems, in-process and finished products, containers, components, and raw materials.
• Conduct container closure integrity testing of finished products using dye ingress methods.
• Perform particulate matter testing of finished products using the HIAC Liquid Particle Counting System.
• Conduct 14-day sterility testing utilizing a Walker Barrier System isolator.
• Carry out routine environmental monitoring in classified manufacturing areas according to approved plans in coordination with laboratory personnel.
• Perform viable air sampling using SAS 100 and SAS Super 180 instruments.
• Perform non-viable particulate sampling using Met One equipment.
• Conduct viable surface sampling through plating and swabbing techniques.
• Perform personnel monitoring as part of the gowning qualification program.
• Execute utilities sampling, including purified water, water for injection (WFI), gases, and clean steam, in accordance with approved procedures.
• Collect and test microbial bioburden and endotoxin samples from facility water systems and clean steam.
• Collect and submit conductivity and Total Organic Carbon (TOC) samples to the chemistry laboratory.
• Coordinate sampling activities with manufacturing to avoid disruption of operations while maintaining aseptic technique and contamination control.
• Ensure accurate sample identification, labeling, traceability, and timely transfer of samples to the quality control laboratory.
• Complete sampling documentation in full compliance with GMP, GDP, and data integrity (ALCOA+) requirements.
• Enter and manage environmental monitoring and laboratory assay data within a digital Laboratory Information Management System (LIMS).
• Trend out-of-specification (OOS) sample results and conduct routine trend analysis of microbiological data.
• Identify trends or atypical results and promptly escalate them to leadership for further investigation.
• Conduct minor and major investigations, including OOS investigations, as necessary.
• Assist with the execution of Corrective and Preventive Action (CAPA) projects related to microbiological and environmental monitoring findings.
• Operate general laboratory equipment, including autoclaves and glassware washers, in accordance with procedures.
• Perform enumeration and verification of sample plates and canisters.
• Handle laboratory waste disposal in accordance with safety and environmental procedures.
• Document sample collection and testing activities clearly and accurately.
• Perform peer review of sampling and testing results to ensure data accuracy and compliance.
• File paperwork and maintain organized laboratory records and documentation.
• Conduct investigations, special projects, or other non-routine sampling and testing as required.
• Train junior analysts in new and existing procedures, techniques, and applicable regulations as directed by supervision.
• Mentor analysts by providing technical guidance, helping resolve technical problems, and reviewing documents.
• Take initiative to seek out additional assignments and contribute proactively to laboratory operations.
• Work safely in accordance with regulations, standards, and procedures to eliminate unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities, or activities that present unreasonable health or environmental risk.
• Report all safety and environmental incidents to management immediately.
• Perform other related duties as assigned by management.

Essential Skills

• Bachelor's degree in Microbiology, Biology, or a similar life science discipline preferred.
• Minimum of 5+ years of laboratory experience, preferably in the pharmaceutical industry.
• Proven ability to perform environmental monitoring of cleanrooms and facility water systems.
• Hands-on experience with kinetic LAL and gel-clot LAL endotoxin testing methods.
• Experience performing filtration testing and particulate matter testing using appropriate instrumentation such as HIAC liquid particle counters.
• Experience conducting 14-day sterility testing using isolator systems such as the Walker Barrier System.
• Proficiency in operating laboratory equipment including autoclaves and glassware washers.
• Strong knowledge and application of aseptic techniques and appropriate cleanroom behaviors.
• Working knowledge of cGMPs, GLPs, USP, FDA, and other relevant regulatory requirements.
• Ability to follow and apply standard operating procedures and approved testing methods.
• Ability to use computer systems for data analysis and documentation, including LIMS.
• Proficiency with Microsoft Excel, PowerPoint, and Access.
• Experience with investigation writing, including OOS and deviation investigations.
• Ability to train personnel on various procedures and communicate effectively with team members and cross-functional groups.
• Good interpersonal skills and strong verbal and written communication abilities.
• Demonstrated self-motivation, energy, enthusiasm, and a team-oriented approach.
• Knowledge of laboratory safety and material safety practices.

Additional Skills & Qualifications

• Experience performing routine environmental monitoring in classified manufacturing areas, including surface, air, and personnel monitoring.
• Familiarity with environmental monitoring equipment such as SAS 100, SAS Super 180, and Met One instruments.
• Experience with utilities sampling for purified water, WFI, gases, and clean steam.
• Understanding of contamination control principles and cleanroom gowning requirements.
• Ability to ensure sample traceability, accurate labeling, and timely delivery to the QC laboratory.
• Working knowledge of data integrity principles, including ALCOA+.
• Ability to identify atypical results and potential contamination risks and to escalate appropriately.
• Experience supporting CAPA activities related to microbiological and environmental monitoring issues.
• Ability to mentor and support junior analysts in resolving technical challenges and ensuring documentation quality.

Work Environment

This position operates in a regulated pharmaceutical laboratory and classified manufacturing environment with a strong focus on cGMP, GLP, and safety standards. Work involves frequent activity in cleanrooms and controlled areas to perform environmental monitoring and utilities sampling, as well as time in the laboratory operating equipment such as autoclaves, glassware washers, isolators, particle counters, and environmental monitoring instruments (SAS 100, SAS Super 180, Met One). The role requires adherence to contamination control practices, aseptic technique, and cleanroom gowning requirements. Documentation is completed in both electronic systems, including LIMS and standard office software, and in controlled paper records, with strict attention to data integrity. The schedule includes shift-based work, with potential assignments from Tuesday to Saturday or Sunday to Thursday, typically on shifts such as 6:00 pm to 2:30 am or 10:00 am to 6:30 pm, depending on operational needs. The environment emphasizes safety, prompt reporting of incidents or unsafe conditions, and collaborative work with manufacturing and other support groups.

Job Type & Location

This is a Contract position based out of Raleigh, NC.

Pay and Benefits

The pay range for this position is $35.00 - $42.00/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 Raleigh,NC.

Application Deadline

This position is anticipated to close on Jun 19, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.