TrackWise Salesforce Digital Platform
Yoelin Mokwena
Validation Engineer
Cape Town
Summary
Experienced Validation Engineer with over 10 years in the pharmaceutical and biopharmaceutical industries, specializing in sterile manufacturing, process validation, cleaning validation, and CQV. Demonstrated expertise in scaling up API facilities, commissioning utilities and equipment, and validating processes for vaccines, drug substances, drug product and Fill-Finish. Proficient in CSV (GAMP 5, SaaS, PaaS), TrackWise QMS, and OnKey Plus for maintenance/calibration integration. Recognized Data Integrity Champion with deep knowledge of data governance and regulatory compliance within GMP environments. Proven ability to lead cross-functional investigations, author validation documents and support product lifecycle management from upstream to fill- finish.
Scientist with solid background in validation processes and regulatory compliance. Known for strong team collaboration and achieving impactful results. Reliable and adaptable to changing needs, with expertise in analytical method development and validation.
Overview
14
14
years of professional experience
5
5
Certifications
1
1
Language
Work History
Validation Scientist
Biovac
10.2016 - Current
- Reviewed and approved System/Process Risk Assessments.
- Compiled, reviewed, and executed Qualification/Validation protocols for Equipment/System, Aseptic Process Simulations (APS), Computer System Validation (CSV), Cleaning Development, Optimization, Consistency and Validation studies.
- Planning and Execution of Cleaning Validation Plans for Developmental, Optimization and Consistency runs for Upstream and Downstream Drug Substance Processes.
- Planning and execution of recovery studies in relation to Cleaning Validation.
- Supported Engineering/APS/PPQ batches and periodic/continuous verification of Vaccine, Drug Substances and Drug Product Processes (e.g., Upstream, Downstream, Formulation, Fill Finish).
- CQV & Computerized Systems:
- Performed commissioning and qualification of Facilities, Utilities, Equipment/Systems, Quality Control Instrumentation, e.g.:
- HVAC
- Access Control (TAAC – Time Attendance and Access Control)
- Clean Utilities (WFI, PW, DI); Black Utilities (Plant Steam, Portable/Softened/Chilled/Hot Water).
- CIP/COP and SIP Systems.
- Parts Washers
- Vial Filling, Closing and Sealing Machine, Labelling and Packing Machines (IPC Fill Weight Statistical Analysis, Capper Qualification)
- TFF Skid
- Lab Equipment Qualification (U/HPLC, Liquid/Gas, UV Spectrophotometer, Total Organic Carbon, Microbiological and Biological Testing equipment)
- Qualified and Validated computerized system as per current GAMP5 and Data Integrity compliance regulations and principles.
- Application of CSV and Data Integrity lifecycle approach for GMP-regulated computerized systems in collaboration with IT and User Departments (PaaS, SaaS, cPMS, DMS, BMS, ONKey Pragma).
- QMS & Investigations:
- Used TrackWise (EQMS) to manage and investigate Deviations, Change Controls, and implemented actions related to CAPAs.
- Collaborated with user departments and QA to investigate and resolve OOSs/Non-Conformances from requalification, qualification, and process failures.
- Compilation and Review of Validation Documentation (Plans, SOPs, Protocols, Risk Assessments, Traceability Matrixes, Reports).
- Compilation of Non-Conformance Reports (NCR) in response to discrepancies encountered during Qualification activities.
- Actively contributed to RCAs, risk assessments, and ensured CAPA implementation for long-term process robustness.
- Collaboration in RCA's, System and Process Risk Assessments with cross- functional teams on-site.
- Compilation of Validation Modules/CPV Reports for updating the APQR (Annual Product Quality Review).
- Maintenance & Calibration Integration:
- Used OnKey Plus Pragma to onboard equipment/systems/utilities for preventive maintenance and calibration.
- Ensured seamless integration of newly qualified systems into the plant maintenance program.
- Leadership & Recognition:
- Mentored Validation interns, graduate program candidates in fundamentals of validation life cycle as per VMP and guidelines.
- Planning and Co-ordination for execution of Process and Cleaning Validation Development, Optimization, Consistency and PPQ Batches.
- Nominated for Bio-Star recognition (CSV of OnKey 5 Asset and Maintenance System).
- Awarded “Best Employee of the Year” for leading Validation Activities for an Up-scale API Facility.
Validation Engineer
Fine Chemicals Corporation
03.2012 - 09.2016
- Commissioning and Qualification of Equipment/Systems and Utilities for up-scaled plants for production of APIs.
- Delegate for co-ordination and leadership of Validation API products and reporting in absence of Validation Manager.
Education
BSc - Biopharmaceutical Science
Atlantic University of Technology
Sligo, Ireland09.2024
ND - Chemical Engineering
Cape Peninsula University of Technology
Cape Town, South Africa07.2013
Skills
Leadership
Adaptable
Planning/Organization
Innovative
Collaborative
Accomplishments
· Mentored Validation interns, graduate program candidates in fundamentals of validation life cycle as per VMP and guidelines.
· Planning and Co-ordination for execution of Process and Cleaning Validation Development, Optimization, Consistency and PPQ Batches.
· Nominated for Bio-Star recognition (CSV of OnKey 5 Asset and Maintenance System).
· Awarded “Best Employee of the Year” for leading Validation Activities for an Up-scale API Facility.
Software
ONKey Enterprise Resource Planning System - Pragma
Certification
GAMP 5 – Computerized Systems Validation (Nov 2021)
Timeline
Validation Scientist
Biovac
10.2016 - Current
Validation Engineer
Fine Chemicals Corporation
03.2012 - 09.2016
ND - Chemical Engineering
Cape Peninsula University of Technology
BSc - Biopharmaceutical Science
Atlantic University of Technology
References
Available on request.
CORE COMPETENCIES
- Process Validation / Process Performance Qualification (PPQ)
- Aseptic Process Simulations
- Continued Process Verification (CPV)
- Cleaning Validation
- Filter Validation
- CQV for Facilities, Utilities and GxP Equipment/Systems and Processes (e.g., CIP/SIP Systems, TFF Skid, Vial Filling Machine, Labelling and Packing Machines, Clean and Black Utilities, HVAC)
- Container Closure Integrity Testing (CCIT)
- CSV (GAMP 5) & Data Integrity and Data Governance Compliance (DI Champion)
- Quality Systems: DMS, BMS, cPMS, TrackWise, OnKey Plus
- QMS Support: Raising/Initiation/Investigation and closure of Deviations, CAPAs, Change Controls
- Validation Lifecycle Documentation (Validation Plans, URS, FS, RTM, SRA, FAT/SAT, Commissioning, IQ, OQ, PQ)
- Periodic Requalification
- Risk-Based Qualification approach.
- Validation using a Quality by Design (QbD) approach.
- GMP Compliance, GxP Utilities, Equipment, and Software
- Cross-functional Investigations (Deviations, OOS, NCs)
- Leadership, Mentorship of Validation Interns/Officers & Inter-Departmental Collaboration