Description:
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
12 Dec 2025;
from:
gumtree.co.za