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R&D Engineer

1 week ago

Cape Town, Western Cape, South Africa Watchmaker Genomics Full time

About the Role

Watchmaker Genomics is seeking an experienced R&D Scientist to join our Process Development team in Cape Town, South Africa. As part of this team, you will apply your expertise in process engineering to design and transfer reagent manufacturing processes.

Your Key Responsibilities

  • IDentifying critical process parameters (CPPs) that ensure critical-to-quality attributes (CQAs) are consistently achieved.
  • Developing or adapting processes to meet CPPs by investigating new methods, equipment and controls, and confirming suitability through experimentation.
  • Identifying opportunities for process streamlining, standardization, and alignment with industry best practices.
  • Planning and executing assigned project deliverables and proactively communicating status and outcomes.
  • Contributing to process, equipment, and computer systems validation, as well as material qualification, by establishing clear, testable specifications based on CPPs and CQAs, along with associated experimental planning.
  • Identifying and documenting process risks, assessing potential impacts, and developing appropriate mitigations.
  • Designing robust, rigorous experiments for the development and testing of new processes and comprehensively document outcomes.
  • Having a working understanding of the ISO13485 standard and internal standard operating procedures (SOPs) to effectively apply these principles.
  • Supporting on-market products by investigating process-related issues through data trending, analysis, or experimentation.
  • Authoring and revising work instructions, batch record templates, and other production-facing documentation that are clear and concise to ensure reproducible results.
  • Preparing training materials and conducting classroom and on-the-job training of operators on new or revised procedures.