MS&T Specialist I
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Stefanini Group is hiring!
Exciting opportunity awaits let us help you get started!
Click Apply now or you may call Ghanshyam Sharma at 1 or email at 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 Masters 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: Masters 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.
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.
Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives
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. We are CMM Level 5 company.
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Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
