Yamkela Nkwezi
Production Technician
23 Steve Karnovertz, Nyanga, Cape Town
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Work Preference
Work Type
Full TimeContract WorkPart TimeInternshipLocation Preference
On-SiteHybridImportant To Me
Company CultureFlexible work hoursPersonal development programsPaid sick leavePaid time offSummary
Dynamic Filling Technician with a proven track record at Afrigen Biologics and Vaccines, excelling in regulatory compliance and precision filling. Enhanced production efficiency through effective team collaboration and problem-solving, while upholding stringent quality standards. Committed to continuous improvement and optimizing processes, ensuring high-quality outcomes in a fast-paced environment.
Professional in production processes with strong focus on precision and efficiency. Deep experience in equipment operation, troubleshooting, and maintenance. Reliable in team collaboration and adaptable to changing needs. Skilled in quality control, safety protocols, and process optimization. Developed expertise in fast-paced production environment, demonstrating strong technical skills and attention to detail.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Production Technician
Afrigen Biologics and Vaccines
Cape Town
09.2025 - Current
- Executed continuous improvement initiatives to streamline production processes.
- Collaborated closely with cross-functional teams for seamless coordination of production activities and timely delivery of finished goods.
- Increased workplace safety, conducting thorough hazard assessments and implementing corrective actions.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Troubleshot equipment malfunctions quickly to minimize disruptions in production schedules.
- Trained new team members on equipment operation, safety protocols, and company policies, fostering a skilled workforce.
- Execute activities as per SOP’s and BMR’s relating to Drug Substance, Drug Product, Fill and Finish processes.
- Hands on role executing activities and leading production operations impacting Fill and Finish manufacturing.
- Responsible for batch preparation activities such as cleaning and sterilization of components.
- Draft new SOP’s, Specification, WI, user requirement specification, risk assessments, technical protocols etc. as required.
- Collaborate with specialists for troubleshooting initiatives on product, processes, and equipment issues to ensure that production can continue.
- Ensure that Finished Product is produced, stored and documented in accordance with GDPs principles.
- Participate in equipment installation, commissioning, performance, and operator training.
- Take necessary measures to ensure that the requirements of the Safety, Health and Environment Standard Operating Procedures (SOP’s) are adhered to.
- Ensure that practical steps are taken to identify, manage, eliminate, or mitigate any hazards to employee safety or health related, to work performed, products produced, processed, used, handled, stored, or transported, and any plant or machinery used.
- Establish own work priority and timelines.
- Maintaining facilities and processes in full compliance with the current regulations and guidelines.
- Support Drug Product manufacturing activities.
- Collaborate with cross-functional teams to implement innovative technologies and methodologies.
- Participate in efforts to optimize Fill and Finish manufacturing processes, ensuring efficiency, scalability, and adherence to regulatory standards.
- Collaborate with Quality teams to establish and maintain high-quality standards in Fill and Finish manufacturing.
- Conduct risk assessments, corrective and preventative actions, deviations, change control and investigations to address deviations and non-conformities.
- Assist with qualification of equipment.
- Compilation of GDPs documentation.
- Execute Fill and Finish processes and documented in accordance with GDPs principles.
- Ensure timely and accurate completion of all documentation related to regulatory compliance.
- Responsible for involvement in transfer of new technologies from R&D / CMC into commercial production as production representative.
- Participate in technology transfer and training.
- Participate in training programs to cross-train the manufacturing team and ensure compliance with guidelines.
- Stay abreast of industry trends and share knowledge with the team to encourage a culture of continuous learning.
- Responsible for operating a labelling machine line to ensure that our products are correctly and accurately labelled for traceability.
- Ensured that the filling process was done within the qualified period as per the qualification protocol.
Production Assistant
Afrigen Biologics and Vaccines
Cape Town
12.2023 - 09.2025
- Assistant in operation of equipment in the execution of production runs and cleaning the equipment after the production process according to SOPs.
- Implement and ensure cGMP practices are adhered to during production process.
- Identify opportunities for manufacturing and yield improvements.
- Participate in risk assessment and propose mitigation measures and CAPA.
- Assist with production scheduling and planning in collaboration with production manager.
- Assist in cleaning the production area for production process, ensuring that scales are calibrated for weighing raw materials and finished products before & after formulation run.
- Assist in preparation for dispensing raw materials by cleaning the dispensary room and cleaning the dispensing tools according to BMR and SOPs.
- Took charge in ensuring cleaning of graded areas and ungraded areas as per SOP.
- Ensure that the cleanroom garments are in place for the staff.
- Assisted with various activities of production including formulation, filling, and packaging of a manufactured product.
- Assisted in producing high-quality products by adhering to strict manufacturing standards and protocols.
- Maintained a safe and clean work environment, contributing to overall team productivity.
- Collaborated with production team to facilitate smooth operations, avoiding disruptions and delays
- Collaborated with the Production and Quality assurance team to resolve a customer complaint within a day.
Education
Associate of Applied Science - Pharmacy
04.2001 -
- Completed Coursework: Pharmacist Assistant, 10/2025
Skills
Testing and troubleshooting
Machine operation
Root-cause analysis
Production optimization
Assembly line experience
Equipment calibration
Clean room procedures
GMP regulations adherence
Dispensing of raw materials for (complementary medicines) and buffers for mRNA drug substance and drug product
Compounding skills: proficient in preparing complementary medicines and buffers for mRNA drug substances and products
Equipment operation: experienced in operating the pistol filling machine and Dyhydromatics High Shear Homogenizer
Filling line operation: skilled in operating the FPC60 vial filling machine within a classified grade B environment (oRABS)
Operation of bb labelling machine
Equipment Operation: Experienced in operating the Pistol Filling Machine and Dyhydromatics High Shear Homogenizer
mRNA Vial Filling Line Operation: Skilled in operating the FPC60 Vial Filling Machine within a classified Grade B environment (oRABS)
Operation of BB Labelling machine
Certification
S'Buys Academy - [Pharmacist Assistant Post Basic]
Languages
English
Intermediate (B1)
Xhosa
Advanced (C1)
Timeline
Production Technician - Afrigen Biologics and Vaccines
09.2025 - Current
Production Assistant - Afrigen Biologics and Vaccines
12.2023 - 09.2025
S'Buys Academy - Associate of Applied Science, Pharmacy
04.2001 -