Production Technologist equipped with extensive experience in the Veterinary Pharmaceuticals Industry. Adept in cell culture, viral & bacterial antigen manufacturing, quality control and vaccine formulations. Very eager further diversify my knowledge and skills within the biological sphere.
Overview
5
5
years of professional experience
5
5
years of post-secondary education
Work History
Production Technologist
ONDERSTEPOORT BIOLOGICAL PRODUCTS
Pretoria
06.2020 - Current
Responsible for propagation and maintenance of high quality working cell lines: BHK, CFK, MDBK and Vero cells in accordance with SOP’s and regulatory requirements
Managing technical assistants performance and ensure training, competency, and skills development plans are in place.
Reviewed SOPs, batch documents, operational risks and participate in quality assurance audits.
Configured production structures on Navison Enterprise Resources Planning platform and ensured adequate stock management.
Collaborating with operations departments involved in upstream and downstream processing of raw materials and/or vaccine products to compile and implement monthly production schedules and streamline process
Improved production efficiency by maintaining 95% production success rate and yield outputs.
Conduct research and implementation of improved production technologies as part of continuous improvement.
Conduct quality control & performance testing of intermediate raw material and consumables utilized during production.
Process control management; ensured database are updated and results trending reported monthly
Troubleshooting and analysis of product failure incidents; efficient submission and completion of NCR reports and CAPA actions.
Timeous procurement of consumables and new Equipment as per Capex plan; ensuring equipment service/validation and maintenance.
Adhered to SHEQ Compliance in terms of the OHS ACT, ensuring compilation and submission of reports Accidents/incidents, equipment management, environmental impact for operations
Manufacturing Technologist
DELTAMUNE PTY
08.2019 - 02.2020
Manufacturing and bottling of vaccines, biological products, and subcontracted product as per standard operating procedures and in compliance with cGMP and ISO 9000 requirements
Efficient preparation, completion, and review of production batch records
Maintenance and servicing of formulation plants and supporting equipment in compliance with legal and safety requirements
Planning, design, construction and commissioning of new equipment and processes as required by QA department
Assist in implementation of quality systems in various departments within scope of operation
Follow TQMS requirements and timeously perform investigations as needed
Manage team tasks and ensure continued efficient productivity ; ensure that team receives training on SOP’s and that training files are maintained
Compile skills development plan for staff and scheduling relevant training and provide training where needed.
Production Technologist
DELTAMUNE PTY
02.2017 - 07.2019
Plan, perform, and co-ordinate services rendered to various departments to ensure continuity within the production line by providing services to fermentation, quality control, freeze dried products, and final vaccine manufacturing
Maintain service systems and ensure logbooks are completed i.e
Boiler, pure steam, R.O water plant, air compressor, generator, fridges, incubators, etc
Ensure that preparation, completion, and review of production batch records and data sheets is achieved timeously
Conduct various sampling for QC purposes i.e
Environmental monitoring, raw materials, final products, and water
Performing sterility and viability tests for bacterial antigen
Sterility determination of liquid raw materials and final products
Potency and moisture determination of lyophilized viral stocks; Determination of formaldehyde percentage and viscosity of manufactured vaccines
Up-stream processing of bacterial culture for production of antigen
Fermentation and operation of bioreactors and pressure vessels for in-situ sterilization
Cultivation of viruses in chicken embryo for production of antigen