Key Performance Areas

• Co-ordinate activities relating to the production of Mo-99 and I-131 in compliance with the DMF, procedures and customer specifications
• Co-ordinate and compile daily, weekly, monthly and annual API (Mo-99 and I-131) production plans and reports
• Ensure that the target plates for Mo-99 production are available for production
• Co-ordinate and verify the selected columns to be processed for each I-131 batch
• Liaise with Marketing and Sales for the sales plan and contracting thereof, as well as the status of product availability
• Ensure that all batches produced are within specifications (compliance on RCP, RNP, pH, appearance, activity concentration)
• Ensure that customer orders are dispensed accurately, and meets the internal cut-off times specified on the ODMS
• Ensure that deviations and CAPA’s are managed as per procedure and are minimised
• Ensure that events are closed as required by relevant procedures
• Co-ordinate all I-131 and Mo-99 production troubleshooting
• Generate product predictions prior to monthly production
• Ensure that post-production clean up steps are executed, and evidence thereof is available
• Encourage continuous improvement at all times
• Oversee critical Mo-99 and I-131 production activities
• Contribute to Change Control Notice (CCN) and Nuclear Facility (NFSC)

Ensure compliance to cGMP and GDP requirements:

• Ensure that all documents (Proper training required with a test), get qualified, and co-ordinate to ensure that all requirements relevant to RAD Production are adhered to. Keep the evidence of compliance
• Ensure that all SOPs and other documents needed for RAD operational activities are available and kept current
• Ensure that work is done in accordance with relevant procedures, and that relevant quality records are completed (e.g. route cards, forms etc.)
• Review generated records and ensure that they comply to GDP requirements
• Ensure that critical equipment is identified, validated and that their calibration status is kept current
• Manage the daily and monthly verification's of ionisation chambers, balances, and that relevant records are generated;
• Ensure that personnel are adequately trained and authorised, (practical and theoretical training, including certification) and that their training records are kept current
• Ensure that audit actions are closed out effectively on target dates as agreed to with relevant stakeholders
• Ensure that overall quality objectives are met as per NTP Quality Policy

Ensure internal and external customer satisfaction:

• Ensure that the dispensed production consumables function according to expectation (e.g. No leaking pipes/tubing, no foreign substances in dispensed consumables, etc.)
• Ensure that the correct consumables for dispensing customer’s orders are requested at all times
• Ensure that customers get their orders/requests on time and within specifications

Ensure that SHEQ goals are achieved:

• Ensure compliance to facility license requirements and Operating Technical Specification (OTS) (Training required on the system)
• Ensure employee compliance to safety and the use of PPE
• Maintain radiation worker’s status in RAD Production (by ensuring that they write and pass radiation worker exams, attend whole body counts, attend statutory training and attend all compulsory safety presentations)
• Ensure that SHEQ processes are maintained and that related audits are successful
• Ensure that safety events are investigated and closed out effectively within target dates
• Assist NTP in achieving its overall SHEQ target
• Ensure compliance to overall safety as per Safety Policy Statement

Planning and Leadership Activities:

• Ensure proper planning for the smooth running of production activities
• Procure the IN-CELL equipment and accessories as needed in order to maintain production
• Determine the staff requirements, permanent and contractors, in accordance with the expected deliverables

Conduct performance planning and compile the performance management documentation in collaboration with the staff member in terms of:

• Personal Development Plan
• Continuously provide feedback and coaching to manage that the staff member/s performs at optimum productivity level
• Conduct performance reviews in accordance to the policies and procedures and take corrective actions where necessary;
• Exposure to cGMP, GDP and ISO9001:2015 audits would be advantageous
• Exposure to Change Management, and basic understanding of acts, such as BCEA, EEA, OHSA, etc.
• Proven track record of managing a plant
• Report writing capabilities
• Must portray leadership skills and be a team player

A leading global company is seeking an experienced Production Engineer based in Pretoria