Microbiologist II (3rd Shift)

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
• 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)
• Auxist 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 , , , , ) 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