KEEGAN TOMMY
Validation Specialist
Vorna Valley
Summary
Validation specialist with extensive expertise in quality assurance and regulatory compliance, ensuring the accuracy and reliability of processes and systems. Demonstrated proficiency in data analysis, process validation, and risk assessment, with a strong focus on team collaboration and adaptability to evolving needs. Recognized for driving validation protocols that contribute to successful project outcomes while maintaining compliance with industry standards. Committed to leveraging analytical skills to support product validation and troubleshoot issues, ensuring robust and reliable processes in dynamic environments.
Overview
10
10
years of professional experience
Work History
Validation Specialist and R&D Technician
TRT Manufacturing
Midrand, South Africa
08.2022 - Current
- Validation Specialist Duties:
- Perform Validation on manufacturing process of new products and new plant equipment’s.
- Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
- Construct reports based on validation performed, to be sent to clients like Unilever, L’Oréal, Dabur, Marico, Amka and more.
- Understand the manufacturing process of other companies and extrapolating that information to suit our plant.
- Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
- Enhanced product quality through rigorous testing and data analysis of manufacturing processes.
- Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
- Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
- Reduced process variability with the development of robust validation protocols and procedures.
- Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
- Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
- Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
- Improved validation processes by implementing risk-based approaches and streamlining documentation.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
- Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
- Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
- Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
- Participated in external audits conducted by regulatory authorities demonstrating a high level of expertise and preparedness during inspections.
- Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
- Documented entire validation process, noting changes or alterations completed.
- Explained highly complex information in terms easily understood by non-technical personnel.
- Identified causes of equipment failures and made suggestions for issue resolution.
- Produced and maintained technical documentation for project reference.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Drove corrective actions to accomplish project closure and recurrence control.
- Developed innovative solutions to complex technical problems, resulting in optimized production processes.
- Troubleshot and resolved equipment and process issues.
- Development of new products based on client specifications and requirements.
- This includes but not limited to formulating products, lab scale and pilot scale size for new formulations, adjustments of formulations and more.
- Improving of existing products.
- Create a costing model of new formulations.
Validation Specialist and R&D Technician
KAS Africa (Previously known as Le-Sel Research)
Midrand, South Africa
10.2018 - 08.2022
- Validation Specialist Duties:
- Perform Validation on manufacturing process of new products and new plant equipment’s.
- Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
- Construct reports based on validation performed, to be sent to clients like Unilever, L’Oréal, Dabur, Marico, Amka and more.
- Understand the manufacturing process of other companies and extrapolating that information to suit our plant.
- Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
- Enhanced product quality through rigorous testing and data analysis of manufacturing processes.
- Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
- Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
- Reduced process variability with the development of robust validation protocols and procedures.
- Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
- Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
- Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
- Improved validation processes by implementing risk-based approaches and streamlining documentation.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
- Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
- Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
- Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
- Participated in external audits conducted by regulatory authorities demonstrating a high level of expertise and preparedness during inspections.
- Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
- Documented entire validation process, noting changes or alterations completed.
- Explained highly complex information in terms easily understood by non-technical personnel.
- Identified causes of equipment failures and made suggestions for issue resolution.
- Produced and maintained technical documentation for project reference.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Drove corrective actions to accomplish project closure and recurrence control.
- Developed innovative solutions to complex technical problems, resulting in optimized production processes.
- Troubleshot and resolved equipment and process issues.
- Development of new products based on client specifications and requirements.
- This includes but not limited to formulating products, lab scale and pilot scale size for new formulations, adjustments of formulations and more.
- Improving of existing products.
- Create a costing model of new formulations.
Manufacturing Technician
Le-Sel Research
Midrand, South Africa
07.2018 - 09.2018
- Duties:
- Documented all manufacturing activities, maintaining accurate records for reporting purposes and quality assurance audits.
- Troubleshot equipment issues, minimizing downtime and keeping production on track to meet deadlines.
- Maintained a safe work environment by enforcing safety protocols and conducting routine inspections.
- Trained and supervised production staff in use of equipment and machinery.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Made sure that products were produced on time and are of good quality.
- Collaborated with engineering teams to identify areas for process improvement and develop innovative solutions.
- Conducted thorough testing on finished products, ensuring compliance with industry standards and customer requirements.
- Utilized Lean Manufacturing principles to eliminate inefficiencies and maximize productivity throughout the facility.
Utility Attendant
Le-Sel Research
Midrand, South Africa
04.2018 - 06.2018
- Duties:
- Facilitated prompt resolution of maintenance issues by swiftly reporting problems to appropriate personnel.
- Contributed to a safe work environment through strict adherence to safety guidelines and protocols.
- Proactively participated in ongoing training opportunities to enhance skills and stay current on industry best practices.
- Promoted a healthy working environment by adhering to established sanitation procedures during daily tasks.
- Enabled seamless workflow transitions between shifts through effective communication regarding task updates.
- Reduced equipment downtime by performing regular inspections and preventive maintenance tasks.
Chemical Operator (Learnership)
AECI Chempark
Kempton Park, South Africa
08.2017 - 03.2018
- Duties:
- Operated chemical processing equipment successfully while adhering to company standards.
- Successfully operated chemical reactors, pumps and centrifuges to produce commercial-grade products.
- Implemented safety protocols and procedures for safe, efficient process operation.
- Followed all waste handling guidelines to minimize waste generation.
- Stored, retrieved, mixed, and monitored chemicals used in production process.
- Troubleshot equipment and process issues and restored optimum function to maintain production speed and meet quality goals.
- Followed safety processes and protocols while moving hazardous chemicals and operating heavy machinery to avoid and accidents.
- Tracked and documented production data to maintain accurate records.
International Summer Internship researcher
International Space Elevator Consortium
Remote
06.2017 - 09.2017
- Duties:
- Conduct Interview with Space program leader in South Africa on a new concept for Space Elevator and as to how South Africa can contribute to the development of a Space Elevator with the intention of all Research and Report for publishing.
- Presented research findings at national and international conferences, raising the profile of the institution.
- Collaborated with interdisciplinary teams to conduct comprehensive studies and generate valuable insights.
- Designed experiments with rigorous controls to maximize validity of findings.
- Synthesized large volumes of information, identifying key trends and patterns relevant to research objectives.
- Applied ethical considerations throughout all stages of the research process, safeguarding participant welfare and data integrity.
- Increased research visibility, presenting findings at international conferences.
- Translated complex research findings into actionable recommendations for industry stakeholders.
- Conducted fieldwork in diverse environments, adapting methodologies to unique challenges encountered.
- Reviewed technical and professional publications and journals to stay current on recent literature and make more strategic research decisions.
Temp – Salesperson
IN Industries
Hatfield, South Africa
04.2017 - 05.2017
- Duties:
- Sales of lubricates, petroleum and other chemicals to mining industries.
- Worked to build relationships with customers and built potential for additional sales.
Private Tutor
Private personal work
Remote
08.2016 - 11.2016
- Duties: Tutoring High school and University Students in Mathematics and Physical Science.
Internship – Assistant Plant Manager
Epic Foods pty (ltd)
02.2016 - 07.2016
- Duties:
- Led root cause analysis investigations into production issues, implementing corrective actions to prevent recurrence effectively.
- Supported Plant Manager in establishing strategic objectives for the facility, aligning with broader company goals.
- Managed direction and planning for plant with focus on optimization of daily functions, exceeding customer expectations, and achieving KPIs.
- Directed employees and related programs to maximize team productivity and facility output.
Education
High School Diploma -
Southview High School
South Africa 04.2001 -
Nation Diploma - Chemical Engineering
University of Johannesburg
Johannesburg, South Africa 04.2001 -
Skills
Validation protocols
Cleaning validation
Process validation
Test method validation
Change control
Equipment qualification
Facility validation
Effective communication
Process analysis
Teamwork and collaboration
Problem-solving abilities
Multitasking
Analytical thinking
Quality assurance
Report writing
Accomplishments
- Accepted into the Sci-Bono (Sasol Inzalo) Program Part of the Sci-Bono Program for full 3 year.
- Built a professional (Flyable) Rocket 1st Place in the ASR (Aerospace Research) Rocketry.
- Competition Awarded Level 1 Rocketry Certificate
- Met with Mrs. Michelle Obama during her visit to South Africa
- Completed Summer Internship program with the International Space Elevator Consortium, as the only non-American student.
- Varies others.
- Improved on the formulation of a product for a certain client. (Cannot specify due to confidentially agreement.)
- Developed a project to reduce the negative effect of effluent water produce by a factory.
- Currently working on an invention for a new form of renewable energy.
- Developed a plant for an upgraded reverse osmosis plant for bottling water.
References
- Pete, Swan, US Citizen, International Space Elevator Consortium, Skype Contact: peteswan1
- Lindsay, Sham, TRT Manufacturing, Contact: +27 10 006 2057
Timeline
Validation Specialist and R&D Technician
TRT Manufacturing
08.2022 - Current
Validation Specialist and R&D Technician
KAS Africa (Previously known as Le-Sel Research)
10.2018 - 08.2022
Manufacturing Technician
Le-Sel Research
07.2018 - 09.2018
Utility Attendant
Le-Sel Research
04.2018 - 06.2018
Chemical Operator (Learnership)
AECI Chempark
08.2017 - 03.2018
International Summer Internship researcher
International Space Elevator Consortium
06.2017 - 09.2017
Temp – Salesperson
IN Industries
04.2017 - 05.2017
Private Tutor
Private personal work
08.2016 - 11.2016
Internship – Assistant Plant Manager
Epic Foods pty (ltd)
02.2016 - 07.2016
High School Diploma -
Southview High School
04.2001 -
Nation Diploma - Chemical Engineering
University of Johannesburg
04.2001 -