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COMPANY: NTP Radioisotopes SOC Ltd

DIVISION: Production

DEPARTMENT: Radiochemical Production

VACANCY: Production Engineers

SALARY BAND: Market-related

REF NO: EC15511

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ABOUT NTP RADIOISOTOPES:

NTP Radioisotopes SOC Ltd is a subsidiary of the South African Nuclear Energy Corporation (Necsa). We are headquartered at the world-class Pelindaba Nuclear Facility near Pretoria, South Africa.

NTP is a leading global producer and supplier of radioisotope-based diagnostic imaging and therapy products, and exports to 50 countries around the world.

The NTP brand is built around values of excellence, safety, accountability, reliability and growth. Transformation is at the very heart of what we do at every level and we are committed to an extensive cultural change process that will enable us to ensure our world-class legacy well into the future.

As part of ensuring the sustainable, profitable future of nuclear radiation products, we have committed to systemic engagement with and improvement of our business relationships with partners and subsidiaries, and ensuring that our operating model, our leadership, and our people are supported and enabled through these processes. Enterprise Development forms a key part of our strategy for sustainability.

For more information on NTP Radioisotopes SOC Ltd visit: www.ntp.co.za

POSITION OVERVIEW

NTP has a vacancy for a Radiochemical Production Engineer. The incumbent will be responsible for coordinating and ensuring the smooth operation of the entire Molybdenun-99 (Mo-99) and Iodine-131 (I-131) Production Cycle, from planning to producing and supplying customers with Mo-99 and I-131 in compliance to Customer specifications, just in time (JIT) delivery, radiochemical purity, radionuclidic purity, activity concentration, and other product related specifications.

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The Radiochemicals Production Engineer is also responsible for ensuring that the Mo-99 and I-131 Production unit operations are carried out in full, complies with laws of the country, facility nuclear license, applicable cGMP requirements, and Necsa Group’s applicable policies

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; and Contribute to Change Control Notice (CCN) and Nuclear Facility Safety Committees

(NFSC).

Ensure compliance to cGMP and GDP requirements:

Ensure that all NTP-PRG 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 verifications of ionisation chambers, balances, and that

relevant records are generated;

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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; and

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; and

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 targets; and 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:o Key Performance Areas; ando 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;

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Conduct Human Resources activities in accordance with policies, procedures and legal requirements and within time frames;

Ensure that tasks are completed within the deadlines and often at short notice.

Facility Housekeeping:

Ensure that cleaning SOPs for hot cells and processing equipment are available, kept current and implemented successfully.

Ensure that waste in hot cells is segregated, and cross-contamination of Low Level Waste and High Level Waste is avoided.

Ensure that waste in the hot cells is kept as minimal as possible. Ensure that the cells are cleaned. Ensure that waste volumes comply to OTS and facility license limits, and that there is

adequate liquid effluent storage space before each production run starts; and Develop a housekeeping checklist for the Blue Area and Production Hot Cells, and

ensure that weekly housekeeping inspections are done, and records thereof are generated.

Identify and mitigate risks applicable to RAD Production:

Liaise with QA to draft and comply to risk assessment documents; and Liaise with QA to ensure compliance to the department validation plan.

Job Requirements:

Basic knowledge and understanding of nuclear production. Very good knowledge and understanding of all aspects of engineering, with specific

reference to systems engineering. A strong background working in a production environment/ plant. Sound knowledge of the different business systems, associated applications and the

interrelationship between the business systems. Knowledge and understanding of the company policies and procedures applicable to the

specific work environment to ensure that work outcomes are compliant to the policies and procedures.

Work shifts as required by the business.

Qualifications and Experience:

Preferably B Eng in Chemical/Mechanical Engineering or equivalent. GCC Factories/Plant/Production Environment is required. Registration as a Professional Engineer is an additional advantage. At least five (5) years production experience having served in a Radiochemicals or

similar production environment. Minimum five (5) years’ experience in radiological operations facility.

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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.

Closing date: 08 November 2019.

CONTACT PERSON

Ms Joy Tsoku

Tel: 012 305 4342

Building: Beva C4, Room 2/28, Pelindaba

Please forward your updated CV with certified copies of your educational qualifications to vacancy@ntp.co.za

Important: The suitable candidate will be selected with the intention of promoting representatives and achieving EE targets as contemplated in the relevant NTP Employment Equity Plan.

GENERAL: In line with the Employment Equity Act 55 of 1998, a thorough selection process inclusive of an assessment battery will be used in order to determine whether a candidate has the necessary competencies that are inherently required to perform the role successfully.

Should you not hear from us within 30 days of the closing date, please consider your application unsuccessful.

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