Harishyam M S

Research and Development Technician @BWXT

Kanata, ON, CA

Contributing to the development, scale-up, and transfer of radiopharmaceutical manufacturing processes, working at the intersection of R&D and production to support product commercialization in a highly regulated environment. • Collaborate with cross-functional teams to design, test, and implement robust manufacturing processes and equipment configurations. • Perform hands-on lab and pilot-scale work including process trials, data collection, troubleshooting, and equipment operation. • Prepare and revise technical documentation such as batch records, SOPs, protocols, and reports in alignment with GMP, GDP, and ISO 13485 standards. • Support process validation, equipment qualification, and commissioning activities as part of technology transfer initiatives. • Participate in investigations, deviation reports, and CAPA implementation to drive quality and compliance improvements. • Ensure adherence to safety, radiation protection, and cleanroom protocols while maintaining audit-ready records and data integrity. • Contribute to continuous improvement projects, process optimization efforts, and lean manufacturing initiatives. • Operate within CMC frameworks, supporting regulatory documentation and process development aligned with industry standards.