Job Description

QUALIFICATIONS NEEDED

• Bachelors or higher degree in chemistry/biotechnology/pharmacy/engineering or equivalent

NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE

• 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 in excess of R100 million
• 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
• Experience in the control and monitoring of project progress and risks
• Independent decision makers, able to debate and lead change management
• 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

KEY DUTIES & RESPONSIBILITIES OF THE ROLE

• Ensures that projects are properly scoped with clearly defined deliverables and clear execution plans
• To execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organisational requirements
• 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 for each deliverable and frequently measured and reported
• Ensuring all designs are cost effective and value adding for the company
• 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
• Conduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelines
• Process equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timeline
• Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines
• Ensures process design meets quality criteria

ABC Worldwide