Stefanini, Inc
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Job Details
MS&T Specialist I – Davie, FL (Contract, 9 months, 1 remaining position)
Administrative Job Description Stefanini Group is hiring! Exciting opportunity awaits, let us help you get started!
Click Apply now or call Ghanshyam Sharma at +1 (248) 263-5646 or email Ghanshyam.Sharma@stefanini.com for faster processing.
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.
Job Requirements
Qualifications:
Education:
Master's degree in Microbiology, Biology, or 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.
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.
Pay Range: $ 35.00 - $ 35.00.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting, company with global presence.
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Administrative Job Description Stefanini Group is hiring! Exciting opportunity awaits, let us help you get started!
Click Apply now or call Ghanshyam Sharma at +1 (248) 263-5646 or email Ghanshyam.Sharma@stefanini.com for faster processing.
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.
Job Requirements
Qualifications:
Education:
Master's degree in Microbiology, Biology, or 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.
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.
Pay Range: $ 35.00 - $ 35.00.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting, company with global presence.
#J-18808-Ljbffr