MS&T Specialist I

Job Description

Job Summary:

• The Microbiology & Cleaning Validation Associate supports MS&T activities related to microbiological control, cross contamination, cleaning validation and verification, and TOC-based cleanliness assessment 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.
• The role focuses on sampling execution, data documentation, and on-floor support, risk assessments, investigations, etc. working under the guidance of MS&T scientists and engineers to ensure equipment cleanliness, contamination control, and inspection readiness.

Duties and Responsibilities:

• Perform microbiological and cleaning validation sampling, including swab and rinse samples.
• Create and execute protocols for routine cleaning verification and TOC sampling.
• Apply proper 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.

Education:

• Master’s degree in Microbiology, Biology, Biotechnology.

Experience:

• Entry-level position; internships, academic research, or co-op experience in microbiology or GMP environments preferred.
• Exposure to pharmaceutical manufacturing, quality, validation, or laboratory operations is a plus.
• Digital literacy with exposure to basic AI/ML and use in day to day work.

Skills and Abilities:

• Foundational understanding of Microbiology principles and contamination control and Aseptic and low-bioburden handling practices.
• Awareness of Swab and rinse sampling techniques including environmental monitoring.
• TOC (Total Organic Carbon) principles and applications in cleaning verification.
• Rapid analytical techniques.
• Strong documentation, attention to detail, and data integrity mindset.
• Hands-on, detail-oriented, and quality-focused.
• Comfortable working in manufacturing and controlled environments.
• Strong communication and teamwork skills.
• Willingness to support off-shift or weekend activities as needed during validations or campaigns.

Physical Demands:

• This role involves physical need to reach high points in equipment, tanks, towers and use of lift / ladder / tools to sample difficult to reach locations.
• This role offers an excellent entry point into MS&T, providing exposure to microbiology, cleaning validation, and lifecycle process support in a regulated pharmaceutical environment.