Job Description
Job DescriptionJob Title: MS&T Specialist IShift Schedule: Monday to Friday 8 am – 5 pmTemp to Perm role: Possibility based on workers performance and openingsDuration: 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.
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.
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.
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.