Aviwe Ngeni
Validation Officer
Gqeberha
Summary
Acquired versatile experience in Validation and Reliability Engineering Systems with dual qualifications in Analytical Chemistry and Electronics & Computer Engineering. Currently a Validation Officer at Fresenius Kabi, specializing in IQ/OQ/PQ execution, equipment qualification, calibration, and GMP documentation in the pharmaceutical/API manufacturing sector. Demonstrated expertise in FDA, GxP, and ISO 14644 compliance, skilled in technical report writing, risk assessment, and deviation handling. Proficient in SAP PM, QMS, Kneat Gx, and LIMS systems. Known for methodical problem-solving, collaborative teamwork, and dedication to operational excellence.
Overview
7
7
years of professional experience
4
4
years of post-secondary education
Work History
Validation Officer
Fresenius Kabi
Port Elizabeth, Eastern Cape, South Africa
01.2025 - Current
- Lead IQ/OQ/PQ of utilities, lab, and manufacturing equipment in a GMP-compliant plant manufacturing pharmaceutical injectables.
- Develop and execute validation protocols in accordance with FDA, GxP, and ISO 14644 standards.
- Maintain the Site Master Validation Plan, engineering change controls, and associated re-qualification documents.
- Conduct risk assessments and support investigations of non-conformances; implement corrective actions.
- Ensure strict adherence to GDP for all validation records and audit readiness.
- Supervise and mentor technicians and interns during validation projects.
- Tools used: Kneat Gx, MedgeTech, Ellab, LIMS, SAP Instore.
Reliability Systems Assistant
Fresenius Kabi
Port Elizabeth, Eastern Cape, South Africa
08.2023 - 12.2024
- Supported engineering and maintenance functions with SAP PM system administration and training.
- Monitored execution of maintenance plans and ensured closure within timelines.
- Prepared KPI reports and T&A analysis for performance tracking and budget control.
- Trained technicians in SAP PM use and contributed to system optimization.
- Participated in contractor SHE compliance tracking and documentation.
Filling Operator
Fresenius Kabi
Port Elizabeth, Eastern Cape, South Africa
03.2022 - 07.2023
- Operated and maintained filling and packaging equipment in a cleanroom setting.
- Performed format changes, basic maintenance, and environmental sampling.
- Identified gaps in maintenance programs and engaged technical staff for solutions.
- Trained junior operators on equipment handling and compliance procedures.
Laboratory Analyst
Heraeus
Port Elizabeth, Eastern Cape, South Africa
02.2018 - 01.2019
- Conducted laboratory analysis including spectrophotometry, gravimetric testing, effluent analysis, and pH testing.
- Ensured compliance with internal quality standards for raw materials and finished products.
Education
BEng - Electronics and Computer Engineering
Durban University of Technology
Durban, South Africa 01.2019 - 01.2021
National Diploma - Analytical Chemistry
Nelson Mandela University
Port Elizabeth, South Africa 01.2016 - 01.2018
Skills
- Equipment Qualification (IQ/OQ/PQ)
- GMP / cGMP Compliance (FDA/EU)
- Risk Assessment & CAPA
- SAP PM
- CMMS
- QMS
- Technical Documentation / GDP
- ISO 14644 Compliance
- Validation Protocol Development
- Preventive Maintenance & Reliability
- Team Training & Supervision
Additional Information
Own transport, Sound health, Available for relocation nationally or internationally, Strong technical writing and documentation skills
Training And Certificates
- Advanced Excel Training
- Pharmaceutical Utilities: HVAC, Nitrogen and Compressed Air, Steam, and Water
Systems And Tools
- SAP PM
- SAP MM
- SAP Instore
- QMS
- LIMS
- Kneat Gx
- MedgeTech
- Ellab
- LogTag
- VEMS
Timeline
Validation Officer
Fresenius Kabi
01.2025 - Current
Reliability Systems Assistant
Fresenius Kabi
08.2023 - 12.2024
Filling Operator
Fresenius Kabi
03.2022 - 07.2023
BEng - Electronics and Computer Engineering
Durban University of Technology
01.2019 - 01.2021
Laboratory Analyst
Heraeus
02.2018 - 01.2019
National Diploma - Analytical Chemistry
Nelson Mandela University
01.2016 - 01.2018
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