Description
MicrobiologistSummary of the position: Performs biological assays of clinical and/or commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Guerbet’s standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has mastered most fundamental technical and quality concepts. May provide guidance and training to more junior staff members. Essential Functions & Responsibilities: Perform various microbiological essays, including but not limited to: •Microbial Bioburden of facility water system, in-process/finished products, filling components, raw materials, filling containers/components, and environmental monitoring samples. •Endotoxin testing via Kinetic Turbidimetric Assay and Gel Clot methods for facility water system, in-process/finished products, filling containers/components, and raw materials. •Container Closure Integrity Testing of finished product via Dye Ingress. •Particulate Matter testing of finished product utilizing the HIAC Liquid Particle Counting System. •14-Day Sterility Testing utilizing Walker Barrier System Isolator. Perform Environmental Monitoring (EM) processes, including but not limited to: •Perform viable air sampling utilizing SAS 100 and SAS Super 180. •Perform non-viable particulate sampling utilizing Met One. •Perform viable surface sampling via plating and swabbing. •Perform personnel monitoring as part of gowning qualification program. Perform Sampling of Facility Water System and Clean Steam, including but not limited to: •Collection and testing of Microbial Bioburden samples. •Collection and testing of Endotoxin samples. •Collection and submission of Conductivity and Total Organic Carbon (TOC) samples to Chemistry Laboratory Perform entry and analysis of Environmental Monitoring and Laboratory Assay results, including but not limited to: •Data entry within digital Laboratory Information Management System (LIMS). •Trending of Out of Specification (OOS) sample results. •Conduct routine trend analysis of microbiological data. •Identifying trends or atypical results and escalating to leadership for further investigation. •Conducting minor/major investigations as necessary. •Conducting OOS investigations as necessary. •Assisting with execution of Corrective and Preventive Action (CAPA) projects. General Laboratory tasks as assigned of as evident, including but not limited to: •Operation of the Laboratory Autoclave and Glassware Washer. •Enumeration and Verification of sample plates and canisters. •Laboratory waste disposal. •Sample Receipt and Reconciliation. •Documentation of sample collection and testing. •Peer review of sampling/testing results. •Paperwork filing. •Conduct investigations, special projects, or other non-routine sampling/testing as required. •Conduct training for more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor. •Mentor analysts by providing technical knowledge and support in resolving technical problems and reviewing documents. •Takes initiative; seeks out additional assignments, etc. •Performs other duties as assigned by management Department Specific/Non-Essential Functions: •Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. •Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. •Report all safety and/or environmental incidents to management immediately. •Performs other duties as assigned by management
Skills
Microbiology, environmental monitoring, GMP, Data Analysis
Top Skills Details
Microbiology,environmental monitoring,GMP,Data Analysis
Additional Skills & Qualifications
Education, Experience, and/or Skill: •BS in Microbiology, Biology, or in similar life science preferred. •Minimum 4+ years laboratory experience, preferably in the pharmaceutical industry. •Ability to perform: Environmental monitoring of clean rooms and facility water systems, kinetic LAL, gel-clot LAL, filtration testing, particulate matter testing, 14-day sterility testing, and operation of laboratory equipment (Autoclave, Glassware Washer, etc.). •Knowledgeable of aseptic techniques, clean room behaviors, MC Excel, PowerPoint, Access, and investigation writing. •Ability to train personnel on various procedures and demonstrates effective communication with both team members and other plant support groups. Cognitive Requirements: •Good interpersonal and verbal/written communication skills. •Able to use computer for data analysis. •Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. •Self-motivated, energetic, enthusiastic, and team oriented.
Experience Level
Intermediate Level
This is a Contract position based out of Raleigh, NC.
Pay and BenefitsThe pay range for this position is $32.00 - $40.00/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)
This is a fully onsite position in Raleigh,NC.
Application DeadlineThis position is anticipated to close on Apr 10, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.