Microbiology Technical Lead Full Time Permanent

Microbiology Technical Lead – Cape Town

• Ensures that projects are properly scoped
• To execute the full range of technical project
• To develop technical standards and user requirement specifications.
• Identify and escalate risks and mitigation/recovery plans.
• Create project budget and ensure adherence to the prescribed budget.
• Request approval for changes from necessary stakeholders and manage changes via project change request processes.
• Ensure that the quality criteria is properly defined
• Ensuring all designs are cost effective and value adding
• Execute/provide technical advice for process and or equipment processes.
• Conduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipment.
• Compile the necessary documentation upon completion of manufacturer visit and training.
• Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines.
• Ensures process design meets quality criteria.

• Bachelors or higher degree in chemistry/biotechnology/pharmacy/ engineering or equivalent.
• Good working knowledge of aseptic (sterile) manufacturing processes.
• At least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industry.
• Experience in managing and executing multi-disciplinary projects
• Excellent understanding of process flows and key metrics within a sterile manufacturing environment.
• Excellent understanding of the cGMP guideline relating to sterile products.
• Experience in initiating, planning, executing, and closing projects.
• Able to lead conceptual design regarding processes/ equipment/ structural design etc.
• Microbiological knowledge essential.
• Previous project work and proven ability to convert guidelines into design specs.

Search All Jobs in South Africa →