MS&T Specialist I

Stefanini • Fort Lauderdale, FL

4d • Onsite

About The Position

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.

Requirements

• Master's degree in Microbiology, Biology, Biotechnology.
• Entry-level position: internships, academic research, or co-op experience in microbiology or GMP environments preferred.
• Foundational understanding of: Microbiology principles and contamination control
• Aseptic and low-bioburden handling practices
• 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
• 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.

Nice To Haves

• 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
• Awareness of: Swab and rinse sampling techniques including environmental monitoring
• TOC (Total Organic Carbon) principles and applications in cleaning verification
• Rapid analytical techniques

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees