JOB PURPOSE
As a member of the production shift team, the job holder will operate and monitor the chemical production activities in the plant, ensuring that the product is manufactured within set production schedule and to the required standards of quality in a safe, efficient, responsible and cost effective manner.
REPORTING RELATIONSHIP
The job holder will report to the Shift Supervisor and his deputy working alongside with other chemical technicians.
KEY ACCOUNTABILITIES
1. Operate the different streams of the plant for their specific processes.
Each of these processes comprises the following activities.
a) Handover checks computerised and/or manual.
b) Obtaining, following and completing process related documentation.
c) Pre and post batch cleaning of vessels and lines.
d) Pre batch checks.
e) Charging vessels either manually or via a pump.
f) Post charging checks and taking corrective action where necessary.
g) Adjusting and monitoring process conditions as required to start the process.
h) Monitoring process; both with computer and manually observing temperature, pressure, flow, pH, volume, colour, moisture content and adjusting the parameters accordingly.
i) Carrying out routine sampling and Bulk packing and testing of samples as required.
j) Recognise end point of the reaction and altering process parameter to stop reaction.
k) Transferring product to the next stage.
2. Comply with HSE and quality policies and defined procedures. Bring out unsafe conditions and acts / procedures for correction.
3. Record all operational and analytical data on the appropriate documents and inform the Shift Supervisor of any process abnormalities.
4. Maintain product separation and accurate labelling of all documents, bags and vessels at all times.
5. Carry out routine checks and scheduled cleaning procedures including cleanrooms.
6. Request and collect raw materials and consumables, observe clean areas procedures, monitor raw materials stock and notify Shift Supervisor for any abnormalities.
7. Notify Shift Supervisor of requirements for maintenance. Prepare equipment before maintenance work e.g. depressurizing, cleaning of lines and equipment, de-energizing, LOTO etc.
8. Perform basic maintenance of equipment using tools such as TPM.
9. At the Shift Supervisor's request, to carry out on-the-job training of other Chemical Technicians, incorporating cGMP and safety procedures.
10. To observe cGMP and Health & Safety rules and regulations at work at all times in accordance with Company set standards.
11. To be aware of the potentially hazardous nature of the chemicals in the area and must take the appropriate precautions when using them.
12. Maintain housekeeping of the plant and provide suggestions for improvements.
13. To operate ancillary facilities e.g. water system, tank farms, solvent recovery etc.
CONTACT WITH OTHERS
Internal - Sanofi staff
External - Contractors/Suppliers/Vendors
JOB KNOWLEDGE
- Minimum NITEC or Higher NITEC in Chemical Processing or related
PREREQUISITES
- Must be prepared to work shifts.
- Must be resourceful, conscientious, dedicated and a good team player.
- Adequate formal and on-the-job training on the chemical processes will be given.
TECHNICAL SKILLS
1. Use of process control systems for operation of plant equipment
2. Operation of manufacturing equipment such reactors, centrifuges, filters, dryers etc
3. Cleaning and maintaining cleanliness and condition of cleanroom facility
4. Implement cleaning and changeover of equipment
5. Apply GMP in manufacturing processes
6. Manage materials and materials flow according to established SOP and BRS
7. Able to identify and manage hazards that may occur within biopharmaceutical plant
8. Verify that routine manufacturing processes are consistently within a state of control
9. In-process analysis to verify that results are within targets
10. Able to perform line tracing using P&ID
11. Able to do simple mechanical task such as filter changes.
GENERIC SKILLS
1. Communicate information with others to respond to general inquiries and obtain specific information
2. Digital literacy: Able to use computer software to perform basic functions
3. Interpersonal skills to be able to work with the team and with other departments
4. Basic problem solving to solve simple problems
