MS&T Specialist I

Shift Schedule: Monday to Friday 8am - 5 pm


Temp to Perm role: Possibility based on workers performance and openings


Duration: 9 months with possible extension


Core essential skill sets candidates must have to be considered for the role:
• Recent Master's graduate
• Digital literacy with exposure to basic AI/ML and use in day-to-day work
• Foundational understanding of: Microbiology principles, contamination control, 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.
Job Description

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.
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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 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.
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Qualifications
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
Technical Knowledge & Skills
• Foundational understanding of:
o Microbiology principles and contamination control
o Aseptic and low-bioburden handling practices
• Awareness of:
o Swab and rinse sampling techniques including environmental monitoring
o TOC (Total Organic Carbon) principles and applications in cleaning verification
o Rapid analytical techniques
• Strong documentation, attention to detail, and data integrity mindset.
Personal Attributes
• 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.
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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.