Job Description

Position overview

 

The incumbent will be responsible for developing process solutions for the production of radioisotopes and to provide the necessary supporting technical and process information to ensure that all the regulatory technical requirements are met. These projects could consist of the development of new process and associated facilities, or the modification of existing processes and facilities.

 

Key Performance Areas:

 

IT Infrastructure Design and Management  

  • Translate user requirements statements into technical design requirements 
  • Design and development of technical systems complying with such URS’s 
  • Develop conceptual solutions complying with such requirements 
  • Develop process descriptions 
  • Develop process data sheets as inputs to other engineering disciplines 
  • Develop control descriptions and process interlock descriptions 
  • Develop acceptance criteria for the various design stages, i.e. concept design, basic design, and functional testing of the subsystems as well as the final integrated system 
  • Participate in design and safety review meetings 
  • Compile supporting design files providing traceability of technical decisions to contextual challenges 
  • Develop engineering assessments to demonstrate compliance of design with regulatory requirements 
  • Check working drawings for suitability with respect to the process, space, accessibility, maintenance etc. (P&ID’s and layout drawings) 
  • Consideration of the process safety aspects of projects, which arise from the use of hazardous materials (hydrogen explosion investigation) 
  • Document ‘As-built’ information of existing system / processes 
  • Ensure compliance with regulatory requirements 
  • Update and / or developing SOPs 
  • Support audits 
  • Initiate and manage CCN’s 
  • Establish engineering baselines 
  • Provide technical leadership during construction and commissioning activities 

  

Job Requirements:  

  • Ability to engage with personnel, both internal and external to the organization, e.g. Regulatory, SHEQ, Licensing departments, and Suppliers
  • Innovative and inquisitive 
  • Multi-disciplinary engineering understanding 
  • Understanding the engineering analysis processes 
  • Building and maintaining stakeholder relationships 
  • Communication skills 
  • Strategic planning 
  • Ability to work under pressure and meet targets 
  • Computer literate – Ms Projects and Ms Office 

 

Qualifications and Experience: 

  • B Eng. (Chemical), and Minimum of five (5) years’ experience in process engineering
  • Exposure to cGMP requirements in terms of radiopharmaceutical requirements will be a distinct advantage
  • Minimum of Candidate registration with the Engineering council of South Africa
  • A proven track record in dealing with the requirements of the national regulators will be a distinct advantage
  • A thorough understanding of the production process employed for 99 Mo and 131I will be a distinct advantage 
  • Experience in Radiation Practice will be an added advantage

 

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