Microbiologist II - Sterile

The Microbiologist II is an experienced laboratory professional who independently performs advanced microbiological testing in a cleanroom environment while ensuring strict compliance with regulatory standards and company SOPs. This role carries expanded technical responsibility, including complex testing, equipment maintenance and troubleshooting, data evaluation, and documentation review. The Microbiologist II serves as a technical resource within the laboratory, supports training initiatives, participates in cross-functional collaboration, and contributes to continuous improvement and client-focused projects. What You Will Do Operate independently while maintaining a high level of responsibility for assigned tasks, conducting routine testing on samples—including Sterility, Endotoxin, and Particulate Matter testing—in a timely manner and with minimal supervision, ensuring compliance with regulatory standards. Review schedules and develop plans to guarantee that all required samples are collected and tested on time. Reconcile test samples at the end of the incubation period to confirm proper handling and processing within required limits. Maintain the proper chain of custody for all samples, managing aliquoting, storage, receipt, and shipping effectively. Participate in clean lab operations, preventive actions, and continuous improvement programs to reduce operating costs and enhance efficiency. Perform maintenance, calibration, and troubleshooting of assigned equipment and systems to meet testing deadlines. Promptly troubleshoot and resolve technical issues related to laboratory procedures and cleanroom operations, notifying management of any calibration failures or repair needs. Adhere to company policies and applicable Standard Operating Procedures (SOPs), including ISO 17025, cGMP, cGLP, A2LA requirements, and Quality Control Guidelines. Ensure that SOPs are accurate, up-to-date, and aligned with all required regulatory documents. Calculate, evaluate, and review data, ensuring clear communication of results both verbally and in written format. Draft and review SOPs to ensure consistent execution of laboratory processes. Stay current with technology and instruments, particularly in the areas of microorganisms, equipment troubleshooting, and microbiology/taxonomy issues, while maintaining familiarity with all applicable equipment and systems. Participate in a cross-technology educational program within the laboratory to gain a comprehensive understanding of all functions. Assist with special projects for pharmaceutical and biotech clients, contributing expertise and innovative solutions. Support the training and onboarding of new team members to ensure their competency and compliance with laboratory procedures. Communicate effectively across departments, including Quality Assurance, Client Care, and other internal teams, to ensure smooth workflow and alignment with company objectives. Who You Are Master’s degree in Biology, Microbiology, or a related field, or a Bachelor’s degree with 3+ years of relevant experience in microbiology or a laboratory setting. Preferred experience working with Biological Safety Cabinets (BSC) and in clean room environments. Experience in cGLP or cGMP regulated laboratories is a plus. Demonstrated relevant experience in a microbiology laboratory (Q.C., pharmaceutical, biotech, or clinical lab preferred), with expertise in one or more of the following functions: sterility testing, endotoxin testing, antibiotic assays, environmental monitoring, microbial identification, and/or microbial limit testing (MLT). Strong understanding of microbiology principles and methods, with the ability to communicate this information effectively. Excellent analytical, decision-making, and interpersonal skills, with a high degree of accountability, attention to detail, and integrity in all tasks. Strong teamwork and collaboration skills, with excellent verbal and written communication abilities across disciplines. Proficient in reading, understanding, and complying with company policies and SOPs, including safety rules and regulations. Intermediate computer skills in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint. Ability to maintain focus and complete work in a timely manner, with a willingness to adapt and learn new skills as needed. Ability to execute tasks in a cleanroom environment; head‑to‑toe PPE (including full bunny suit) is required at all times. Ability to stand for extended periods while conducting testing procedures, with the physical dexterity to perform testing accurately and precisely. Frequent use of laboratory equipment and routine exposure to chemicals in a controlled, regulated setting. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr