Microbiologist III (Weekend Day Shift)

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

Weekend Day shift: Saturday - Monday, 7:00 am - 7:00 pm