Cape Town City Centre: Process Development Scientist I

The duties will include, but are not limited to: Collaborate globally with R&D, QA, Operations, Product Management, and Commercial teams to improve the quality, efficiency, and scalability of high-level processes Independently learn, comprehend, and characterise operational processes Integrate data-driven decision making across various departments through implementation of process monitoring, trending, and evaluation Strategically evaluate processes for effectiveness, devise improvements, and implement change Author, revise, and publish process maps, work instructions, batch record templates, risk analyses (e.g. FMEA), and related documentation Create training content, train process users, and build scalable training programs Clearly communicate process designs, analyses, and changes to both technical and non-technical audiences Lead projects and drive change management strategy for improving and scaling various process systems, such as New Product Development, Post-market product care, Manufacturing and Quality Control workflows, and Process development workflows and templates Participate, provide guidance, and lead in non-conformance investigations, root cause analyses, risk assessments, and corrective and preventive actions plans Support a variety of projects aimed at launching products, completing key initiatives, or validating process systems Ensure compliance with all relevant regulatory requirements, including ISO13485 guidelines Other duties as assigned Key Requirements: BSc/BEng in Process/Chemical Engineering with more than 5 years’ relevant industry experience in process engineering or biotechnology, or a PhD in Molecular Biology/Enzymology or related field with more than 2 years’ demonstrated industry experience in process development. Experience with product development, transfer of designs into production, project management, conflict resolution, and working with global teams. Additional Requirements: Proven knowledge of ISO13485 standards and how to operate within a structured quality management system; Six Sigma, 5S, ASQ, Kaizen, or other training/certifications relevant to process improvement; and experience in statistical analysis techniques, such as Design of Experiments, Analysis of Variation, measurements of central tendency, etc. *Only candidates that meet all the requirements should apply Only candidates that are shortlisted will be contacted By sending your application to Scistaff you consent that your information may be kept in accordance with the requirements of the POPI Act.