Process Development Scientist

A global life sciences company is seeking a Process Development Scientist I to join their Process Development team in Cape Town. As part of the Process Development team, you will apply your expertise in process engineering to design and transfer reagent manufacturing processes. You will contribute directly in delivering high-quality, innovative products to our customers. In this highly collaborative role, you will work closely with various departments, including R&D, Production, IT, and Quality Assurance across our global sites.

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 ISO
  13485 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 ISO
13485 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.

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