Andrew Okundia
Portlaoise,Ireland
Summary
Highly experienced senior validation engineer with a strong background in quality assurance of validation documentation, including equipment, utilities, facilities, and process validation. Adept at generating, reviewing, and executing cGMP validation protocols such as IQ/OQ/PQ/QV for systems, equipment, and manufacturing processes. Skilled in temperature mapping, autoclave validation, and Sterilization-in-Place (SIP) procedures. Strong team leader with a track record of delivering validation projects within timelines and ensuring compliance with regulatory standards. Seeking to leverage my experience to support the commissioning and Validation activities on new projects.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
Work history
Snr CQV Engineer
PM Group (Ireland)
07.2023 - Current
- Field execution of commissioning, installation and Operational Qualification activities
- Conducting Qualifications on parts washers and autoclaves
- Attending Factory Acceptance Tests (FAT) at the vendor site
- Performing SIP Temperature Mapping of Upstream Bioreactors, media & buffer Vessels and Downstream vessels
- Livening of Clean steam, Process air and instrument air to various user point
- Sampling of live process gas lines (Nitrogen, CO2 ) using the Lasair equipment
- Overseeing Vendor activities on site during SAT
- Walking Lines in the field with P&ID
- Temperature Mapping of CTUs
- Raising work permit and associated Safe Plan of Action (SPA)
- Manage a team of team members and coordinating task with other departments
- Generate, execute and review of all documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation Master plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV Protocols and reports.
- Trained junior engineers and provided mentorship, enhancing their skill set and knowledge base.
- Cooperated with cross-functional teams during project development stages.
- Led team meetings, fostering effective communication amongst the team.
Snr CQV Engineer
Wuxi Biologics (Wuppertal Germany)
10.2022 - 06.2023
- Performing Temperature Mapping of Autoclave and cycle development of new loads
- Performing Qualification of parts washer
- Performing Qualification of Single use mixers (SUMs)
- Participation in the change control program for modifications to qualified systems
- Performing validation investigations and implement equipment CAPA's and performance improvements
- Generate, execute and review of all documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation Master plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV Protocols and reports.
Snr Validation Engineer
MSD Ireland
04.2022 - 10.2022
- Generate, execute and review of all documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation Master plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV Protocols and reports
- Performing Temperature Mapping of Autoclave
- Performing validation investigations and implement equipment CAPA's and performance improvements
- Identifying and implementing improvements to the QA Validation systems
- Participation in the change control program for modifications to qualified systems.
SnrValidation Engineer (Parenterals)
Pfizer Ireland
05.2019 - 05.2022
- Generate, execute and review of all documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation Master plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV Protocols and reports
- Equipment (Isolators, Product vessels, e.t.c) Qualification/Requalification
- Performing Temperature Mapping of Autoclave, Vessels, and Incubators
- Performing validation investigations and implement equipment CAPA's and performance improvements
- Performing heat sterilization and SIP on product vessels and transfer lines
- Identifies and implements improvements to the QA Validation systems
- Participation in the change control program for modifications to qualified systems
- Performing VHP (Vapor Hydrogen Peroxide) qualification of production Isolators.
CQV Engineer
Alexion Pharmaceuticals
03.2018 - 04.2019
- Author, and maintain the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility
- Implement cleaning strategies for fixed and mobile parts
- Development and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment
- Perform Coverage testing and visual inspections
- Generate and execute cleaning validation protocols, plans and reports as required for API facility
- Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities
- Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operation, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of start-up, technology transfer, and routine manufacturing timelines in the context of cleaning validation
- Author and review cleaning risk assessments, technical protocols and reports, cleaning validation documents, cleaning sample maps and supporting documentation as required.
CQV Engineer
LEO Pharma (Dublin)
02.2017 - 03.2018
- Generate validation protocols and reports
- Execute validation protocols and planning with production and Maintenance department
- Autoclave ReQualification/ Validation
- Performing Temperature Mapping of Laboratory Ovens, Fridges, Warehouse, Cold Rooms, Autoclave, Vessels, and Incubators
- Complete changes associated with change control process and raising deviation and CAPA
- Identifies and implements improvements to the QA Validation systems
- Participation in the change control program for modifications to qualified systems.
Cleaning Validation Specialist
MSD (Brinny Cork)
08.2016 - 12.2016
- Generate cleaning validation protocols and summary reports
- Execute process validation studies for API facility
- Execute cleaning validation protocols, including visual inspection and Swab sampling and coordination with other support groups (e.g
- Operations, maintenance, lab, etc.)
- Autoclave Qualification/ Validation (Cycle development)
- Performing Temperature Mapping of Fridges, Cold Rooms, Autoclave, Vessels, and Incubators
- Complete changes associated with cleaning equipment, cleaning cycles and cleaning program
- Identifies and implements improvements to the QA Validation systems
- Participation in the change control program for modifications to qualified systems.
Cleaning Validation Specialist
Eli Lilly (Kinsale Cork)
08.2015 - 08.2016
- Generate cleaning validation protocols and summary reports
- Review and access change control for API processs
- Execute process validation studies for Large API facility
- Execute cleaning validation protocols, including visual inspection and Swab sampling and coordination with other support groups (e.g
- Operations, maintenance, lab, etc.)
- Cleaning Cycle Development
- SIP temperature mapping in Vessels and Bioreactors
- Generate cleaning procedures and associated work instructions
- Complete Periodic Review Reports for CIP skids and parts washers to ensure cleaning equipment remains in a qualified state
- Complete review of cleaning batch records
- Provide technical support on cleaning deviations/events and assist in root cause analysis
- Complete changes associated with cleaning equipment, cleaning cycles and cleaning program.
Education
Bachelor of Science - Biomedical Science
Institute Of Technology Sligo
Sligo, County Sligo 09.2010 - 06.2013
Bachelor of Science - Medical Biotechnology
Institute Of Technology Sligo
Sligo, County Sligo 09.2013 - 06.2014
Master of Science - Pharmaceutical Validation
Technological University Dublin
Dublin, Leinster 01.2019 - 09.2021
Skills
- Validation Expertise: IQ/OQ/PQ/QV protocol generation, execution, and review for equipment and process validation
- Technical Proficiency: Temperature mapping, autoclave validation, SIP, Delta V, equipment troubleshooting, and cleaning validation
- Documentation Review: Experience in reviewing validation documentation for compliance with cGMP and regulatory requirements
- Change Control: Strong involvement in change control and CAPA implementations
- Team Leadership: Managed cross-functional teams, delivering validation projects on time
- Regulatory Compliance: Comprehensive knowledge of pharmaceutical industry regulations and quality assurance standards
- Presenting experimental data at team meetings
- Technical report writing
- Site inspection
- Safety compliance knowledge
- Knowledge of Delta V
- Production process optimization
- Data interpretation and analysis
- Effective oral and written communication skills
- Capable of working independently in designing experiments and generating data
- Demonstrated ability to work in a team environment and experience various qualitative and quantitative approaches
- Have excellent information technology skills in Excel, Microsoft Word and PowerPoint
Affiliations
- Football, Swimming, Basketball, Tennis
References
References available upon request.
Timeline
Snr CQV Engineer
PM Group (Ireland)
07.2023 - Current
Snr CQV Engineer
Wuxi Biologics (Wuppertal Germany)
10.2022 - 06.2023
Snr Validation Engineer
MSD Ireland
04.2022 - 10.2022
SnrValidation Engineer (Parenterals)
Pfizer Ireland
05.2019 - 05.2022
Master of Science - Pharmaceutical Validation
Technological University Dublin
01.2019 - 09.2021
CQV Engineer
Alexion Pharmaceuticals
03.2018 - 04.2019
CQV Engineer
LEO Pharma (Dublin)
02.2017 - 03.2018
Cleaning Validation Specialist
MSD (Brinny Cork)
08.2016 - 12.2016
Cleaning Validation Specialist
Eli Lilly (Kinsale Cork)
08.2015 - 08.2016
Bachelor of Science - Medical Biotechnology
Institute Of Technology Sligo
09.2013 - 06.2014
Bachelor of Science - Biomedical Science
Institute Of Technology Sligo
09.2010 - 06.2013