Microbiology & Cleaning Validation Associate
hace 3 días
Davie
Job DescriptionTitle: Microbiology & Cleaning Validation Associate Location: Davie, FL 33314 Duration: 9 months with possible extension Shift Schedule: Monday to Friday 8am – 5 pm Temp to Perm role: Possibility based on workers performance and openings 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.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:, • Microbiology principles and 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. 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.#sczr2
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