Microbiologist

Position Overview:

This is a regular, full-time, on-site position based in our New Haven, Connecticut facility.

XingImaging is seeking a highly skilled and meticulous Microbiologist specializing in Environmental Monitoring (EM) and Sterility Assurance to join our Quality Control (QC) team.

This position is critical to ensure the sterility and integrity of our products by rigorously monitoring and controlling our controlled manufacturing environments. If you possess expert knowledge of aseptic processing regulations, cleanroom behavior, and root cause analysis related to microbiological excursions, this is your opportunity to play a key role in public health and safety.

About XingImaging:

XingImaging, a subsidiary of MITRO, is a leading provider of advanced research imaging and radiopharmaceutical services. Our New Haven facility offers a comprehensive range of services, including clinical trial activities and support, advanced imaging, radiotracer manufacturing, and leading imaging analysis services. We are committed to delivering high-quality imaging solutions and accelerating the development of life-saving treatments.

Key Responsibilities:

• Be the subject matter expert (SME) for all microbiological aspects of aseptic processing. Ensure continuous compliance with regulations on sterile drug products.
• Execute routine and non-routine environmental monitoring (EM) of ISO Class 5, 7, and 8 controlled manufacturing areas, including viable air, surface, settling plates, and personnel monitoring.
• Consistently demonstrate and enforce impeccable aseptic gowning and sampling techniques to prevent contamination and guarantee the validity of all monitoring results.
• Collect, process, and analyze samples, including sterility testing of finished products and raw materials when required, utilizing standard microbiological methods and strict adherence to compendial procedures (USP).
• Accurately document, review, and perform advanced trending analysis of EM data. Proactively identify excursions, and non-conforming results, reporting critical deviations to Quality Assurance (QA) immediately.
• Lead or actively participate in complex Out-of-Specification (OOS) and Microbiological Excursion investigations. Focus on identifying the true root cause of contamination events within the aseptic process and propose effective CAPA (Corrective and Preventive Actions).
• Maintain all documentation and laboratory practices in accordance with stringent GMP guidelines, ensuring the facility is prepared for regulatory inspections.

Qualifications and Requirements:

• Bachelor’s degree in Microbiology, Biology, or closely related scientific discipline.
• Minimum of 3 years of experience performing environmental monitoring, sterility testing, and contamination control within a GMP-regulated (Sterile Pharmaceutical or Aseptic Medical Device) manufacturing environment.
• Deep, practical understanding of aseptic manufacturing principles, cleanroom behavior, and terminal sterilization concepts
• Hands-on expertise with microbiological testing techniques, including plate reading, microbial identification, and compendial sterility testing procedures.

Unique Department Requirements:

• Ability to lift up to 50 lbs.
• Awareness that this position requires work in an environment where radioactive materials, including radioisotopes, are handled.

PLEASE NOTE:

Please note that since this is position is onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.

What We Offer:

• Competitive Salary
• Comprehensive Health Insurance Plan
• Long-Term Disability
• Life Insurance
• Retirement Plan

XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.