- Responsible for supporting microbiological sampling, cleaning validation activities, and process verification within a regulated pharmaceutical manufacturing environment.
Experience:
- Entry-level experience with internships, academic research, or co-op experience in microbiology or GMP environments preferred.
- Exposure to pharmaceutical manufacturing, quality, validation, or laboratory operations preferred.
- Exposure to digital literacy concepts and basic AI/ML applications in daily work activities preferred.
Responsibilities:
- Perform microbiological and cleaning validation sampling including swab and rinse sampling activities.
- Create and execute protocols for routine cleaning verification and TOC sampling.
- Apply aseptic and low-bioburden handling techniques during sampling activities.
- Develop and execute TOC-based cleaning validation activities including sample handling and data review.
- Coordinate with Quality Control teams and external laboratories for testing activities.
- Assist with microbial and chemical cleanliness risk assessments for equipment and manufacturing processes.
- Document sampling activities and results in compliance with GMP and ALCOA+ data integrity requirements.
- Support validation, process performance qualification, and process verification activities during product introductions and equipment changes.
- Participate in deviations, investigations, and CAPA activities related to microbiological or cleaning events.
- Collaborate with MS&T, QA, QC, Engineering, and Manufacturing teams.
- Support validation campaigns and off-shift activities as required.
- Perform sampling activities involving access to elevated equipment, tanks, and difficult-to-reach locations using ladders and tools.
Should Have:
- Strong attention to detail and documentation skills.
- Strong communication and teamwork abilities.
- Ability to work in manufacturing and controlled environments.
- Quality-focused and hands-on approach to work.
- Willingness to support weekend or off-shift activities when required.
Skills:
- Microbiology principles and contamination control.
- Aseptic and low-bioburden handling practices.
- Swab and rinse sampling techniques.
- Environmental monitoring awareness.
- TOC principles and cleaning verification processes.
- Rapid analytical techniques.
- GMP documentation and data integrity practices.
Qualification And Education:
- Master’s degree in Microbiology, Biology, Biotechnology, or related field.
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting powerhouse. Proudly recognized as a nationally and locally certified diversity firm, Cynet delivers agile, scalable talent solutions across industries. With an active footprint in all 50 U.S. states and Canada, we support thousands of consultants through our expansive, high-performing recruitment engine operating across North America and Asia—ensuring speed, quality, and consistency in every hire.