Microbiologist III (1st/2nd Shift)

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The QC Microbiologist II supports the microbiological control program in a sterile injectable (parenteral) manufacturing facility. This position plays a key role in maintaining the facility’s aseptic control state by performing environmental and utility monitoring, microbiological testing of raw materials, in-process samples, and finished drug products. The role also includes data review, investigation support, and ensuring compliance with regulatory requirements and cGMP standards. ### Responsibilities - Perform viable and non-viable environmental monitoring in ISO Class 5–8 cleanrooms, including aseptic filling areas (isolators and RABS). - Conduct personnel monitoring to assess aseptic technique compliance. - Collect and test utility samples (WFI, Purified Water, compressed gases) per approved sampling plans. - Trend and assess environmental and utility data to support cleanroom control and sterility assurance. - Perform microbiological assays including bioburden, endotoxin, and growth promotion testing. - Support and handle samples for media fills/aseptic process simulations. - Test raw materials, in-process, and finished products per USP, EP, and internal methods. - Maintain and verify microbial culture stocks, control strains, and reference organisms. - Document all work per cGMP and ALCOA+ principles. - Review, interpret, and ensure accuracy and traceability of analytical data. - Author, revise, and review SOPs, test methods, qualification protocols, and reports. - Summarize data trends and prepare monitoring review reports. - Provide microbiological input for environmental excursion and deviation investigations. - Support equipment and laboratory qualifications (e.g., autoclaves, incubators, isolators, particle counters). - Assist with method validations, verifications, and transfers. - Maintain a clean, compliant, and organized laboratory. - Follow biohazard and waste-handling procedures. - Participate in internal/external audits and provide technical support. - Identify and support laboratory process improvements and automation initiatives. ### Requirements - Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related life science discipline. - 2–4 years of experience supporting QC Microbiology operations for sterile injectables or other aseptically manufactured products. - Hands-on experience with environmental monitoring of cleanrooms and isolators as well as aseptic technique - Working knowledge of compendial methods (USP <61>, <62>, <71>, <85>, <1116>) and regulatory guidance (FDA, EMA, ICH Q7/Q9/Q10). - Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). - Strong attention to detail and commitment to data integrity. - Effective communication skills (written, verbal, and presentation). - Demonstrated initiative, accountability, and ability to work both independently and in cross-functional teams. - Flexibility to support off-shift or weekend sampling and testing based on manufacturing needs. - Ability to work in cleanroom gowning and controlled environments for extended periods. - Frequent standing, bending, and walking. - Ability to lift up to 25 lbs and handle routine laboratory equipment and sampling tools. ### Shift Hours 1st shift: 7:00am - 3:00pm, Monday - Friday 2nd Shift: 3:00pm -11:30pm, Monday - Friday