Likhona Tonisi

Validation Scientist/ Officer

Biovac Institute

Cape Town

01.2022 - 11.2025

Validation protocol creation
Execution of validation processes: VMP, VP, CSV, Mapping, Cold Chain, Facility Decontamination, Periodic Reviews, and Periodic Revalidation as defined timelines and according to cGMP
Product and process validations (IQ, OQ, PQ, APS)
Liaising with internal and external stakeholders to plan and execute validation activities
Validation administration such as updating the validation procedures maintaining schedules, and standard referencing of documentation
Participates in troubleshooting a wide range of problems which requires creative thinking
Exercises significant technical discretion in design, execution, and interpretation, and pursue new validation/qualifications studies as a result of experimental outcomes
Preparation and presentation during internal and external audits
Assist equipment owners with identifying maintenance and calibration requirements
Ensure a state of accuracy across all documentation within its own span of control in support of achieving optimal quality
Communicate status and any delays/ issues/ changes experienced during validation
Equipment qualification, calibration and computerised information systems validation requirements in manufacturing, packing, warehouse, facilities and utilities
Attending Factory Acceptance Test (FAT) for new equipment
Attending Site Acceptance Test (SAT) for new equipment
Undertaking additional duties or specific projects as required
Qualification Activities Include: Qualification of temperature-controlled devices (e.g., ULT Freezers, Incubators, Cold Rooms, Warehouse, Release and Quarantine Stores, Refrigeration Systems), Qualification of sterilization equipment (e.g., Autoclaves, Fermentors, formulation systems), Qualification of biosafety Cabinets, Qualification of Compressed Air System, Qualification of Automated Visual Inspection Machine, Qualification of Labelling and Packing Machines, Qualification of Balances, performed Air Visualization Studies,
Writing SOPs for validation equipment used during execution
Process Validation Activities Including: Aseptic Process Simulation, Media Fill process execution, Transport Validation Activities, Computerized System Validation, Data Integrity Activities, Trackwise system verification, Verification of 21 CFR to inhouse equipment and system
General Activities: Planning and organizing incoming activities, Actively lead and involved in the execution of validation activities, Represent the company to clients (internal & external) as a validation personnel on validation projects, Liaise with key personnel within project teams to ensure validation activities are governed and completed in a timely manner, Regularly update the Validation Lead on validation project status and escalate issues when appropriate, Support ongoing validation lifecycle management to provide confidence that validated systems and processes remain fit for use, Train and mentor those executing validation in the content of the validation exercise & expectations
Led project discussions during line manager's absence.
Worked diligently under pressure whilst preserving high-quality output.
Played an active role in reviewing validation protocols carried out by peers.
Ensured the adoption of science and risk-based methodologies for validation support.
Participated in investigations, identified root causes and implemented corrective actions.
Addressed challenges encountered during project qualification and validation processes.
Developed and delivered training for staff on revised validation SOPs.
Increased compliance with regulatory requirements through rigorous documentation practices and continuous improvement initiatives
Contributed to successful audits by maintaining organized records of all validation activities and results.
Conducted thorough investigations into deviations, identifying root causes and implementing appropriate corrective actions.
Enhanced validation processes by implementing risk-based strategies and utilizing statistical tools.
Executed assigned duties responsibly thus meeting departmental expectations consistently.
Conducted risk assessments to ensure public safety.
Collaborated with colleagues for effective teamwork.