Pinnacle Technology · 8 hours ago
Research And Development Specialist
Pinnacle Technology is a company focused on pharmaceutical manufacturing, and they are seeking a Research And Development Specialist. This entry-level role supports microbiological control and cleaning validation activities, focusing on sampling execution and data documentation to ensure equipment cleanliness and contamination control.
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
Qualification
Required
Master's degree in Microbiology, Biology, Biotechnology and Chemistry
Entry-level position; internships, academic research, or co-op experience in microbiology or GMP environments
Foundational understanding of microbiology principles and contamination control
Foundational understanding of aseptic and low-bioburden handling practices
Document sampling activities and results in compliance with GMP and data integrity (ALCOA+) requirements
Preferred
Exposure to pharmaceutical manufacturing, quality, validation, or laboratory operations
Digital literacy with exposure to basic AI/ML and use in day to day work
Awareness of swab and rinse sampling techniques including environmental monitoring
Awareness of TOC (Total Organic Carbon) principles and applications in cleaning verification
Company
Pinnacle Technology
Pinnacle Technology provides staffing solutions, outsourcing, and systems integration services.
Funding
Current Stage
Growth StageRecent News
GlobeNewswire News Room
2025-02-21
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