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JOB SUMMARY
The Microbiology & Cleaning Validation Associate supports MS&T activities related to microbiological control, cross-contamination prevention, cleaning validation and verification, and TOC-based cleanliness assessments for pharmaceutical manufacturing equipment and facilities. This is a hands-on, entry-level role ideal for a recent Master’s graduate with strong microbiology fundamentals and an interest in applied GMP manufacturing environments.

Key Responsibilities
• Perform microbiological and cleaning validation sampling, including swab and rinse samples.
• Create and execute protocols for routine cleaning verification and TOC sampling.
• Apply aseptic and low-bioburden handling techniques during sampling activities.
• Develop and execute TOC-based cleaning validation, including sample handling, data review, and coordination with QC or external laboratories.
• Assist with microbial and chemical cleanliness risk assessments for equipment and processes.
• Document sampling activities and results in compliance with GMP and data integrity (ALCOA+) requirements.
• Support validation, PPQ, and process verification activities during new product introductions and equipment changes.
• Participate in deviations, investigations, and CAPA support related to cleaning or microbiological events.
• Collaborate cross-functionally with MS&T, QA, QC, Engineering, and Manufacturing teams.
• Perform physical sampling activities, including reaching high points in equipment, tanks, and towers using lifts, ladders, or tools.

Required Qualifications
• Master’s degree in Microbiology, Biology, or Biotechnology.
• Foundational understanding of microbiology principles and contamination control.
• Knowledge of aseptic and low-bioburden handling practices.
• Strong documentation skills, attention to detail, and commitment to data integrity.
• Willingness to support off-shift or weekend activities during validations or campaigns.

Preferred Qualifications
• Internships, academic research, or co-op experience in microbiology or GMP environments.
• Exposure to pharmaceutical manufacturing, quality, validation, or laboratory operations.
• Awareness of swab and rinse sampling techniques, TOC principles, and rapid analytical techniques.
• Digital literacy with exposure to AI/ML applications in daily work.

Education: Masters Degree