Brandon O’Neill
Grovetown
Summary
Results-driven validation and quality assurance professional with 8+ years of hands-on experience in end-to-end validation of equipment, software, utilities and computerized systems, QA compliance, software administration and project management in a GMP FDA regulated pharmaceutical company. Expertise in GMP compliance, GAMP 5, 21 CFR Part 11 and Parts 210/211, risk-based validation approaches, vendor and internal auditing, QMS administration, change control, CAPA management, project management and deviation/CAPA investigations. Proven track record of executing end-to-end validations, supporting backroom activities during regulatory audits, serving as an SME during customer and regulatory audits, administrating GxP software, ensuring data integrity, and supporting successful regulatory audits while improving operational efficiency and compliance.
Overview
8
8
years of professional experience
Work History
Validation Engineer Supervisor
AmbioPharm, Inc
North Augusta, SC
05.2026 - Current
- Developed and executed comprehensive FAT/SAT/commissioning validation protocols for new equipment and processes, ensuring compliance with GxP regulations and successful handover to operations
- Manage the validation engineer team and ensure the timely completion of all new asset validations.
- Administration of the site QMS (MasterControl), CMMS (MasterControl), and all other site GxP software including configuration changes, troubleshooting, helpdesk, and compliance.
- Perform routine 21CFR Part 11 assessments and compliance checks of all GxP software.
- Participated in the back-room of a successful 2026 Health Canada general GMP regulatory inspection of my facility.
- Serve as site QMS, CMMS, software administration, and validation SME.
Sr. Validation Engineer
AmbioPharm, Inc
North Augusta, SC
09.2023 - 05.2026
- Developed and executed comprehensive FAT/SAT/commissioning validation protocols for new equipment and processes, ensuring compliance with GxP regulations and successful handover to operations.
- Administration of the site QMS (MasterControl), CMMS (MasterControl), and all other site GxP software including configuration changes, troubleshooting, helpdesk, and compliance.
- Managed the compliance of the facilities and engineering department including tracking of departmental KPIs, writing deviations, and implementing CAPAs.
- Managed the validation engineering team.
- Participated in the backroom of a successful 2023 FDA General GMP Inspection of my facility.
- Reduced facility and engineering open CAPAs by 60% in 3 months by closing 23 CAPAs.
- Notable Validations: Biosafety Cabinet, 4 Glove Isolator, 100L Horizontal Centrifuge, SmartSheet Custom Inventory Management System, 1000L Tray Lyophilizer, Vaisala viewLinc Enterprise Server Software, MetOne 3415+ Particulate Counters, and Vacuum Sealer.
- Perform routine 21CFR Part 11 assessments and compliance checks of all GxP software.
Associate Manager of Quality Assurance Operations
AmbioPharm, Inc
North Augusta, SC
02.2023 - 09.2023
- Manage the quality operations team ensuring timely review of batch records, product release, and overall site operational quality systems.
- Customer correspondence relaying product updates, timelines, and change controls.
- Review of batch records, CAPAs, deviations, validation protocols, and change controls.
- Operational risk analysis.
- Aided in the sites first pilot peptide synthesis operation through procedure and form updates and other updates to implement peptide synthesis capabilities.
- Perform routine site audits and internal audits of departments and sit in during customer audits as an SME.
Validation Engineer
AmbioPharm, Inc
North Augusta, SC
01.2022 - 02.2023
- Develop validation plans for new site process and analytical instrumentation including the development and execution of commissioning protocols (FAT/SAT), design documents (FRS/DS), qualification protocols (DQ/IQ/OQ/PQ), and validation reports (Trace Matrices and Summary Reports).
- Assist the facilities and engineering department in writing deviations and CAPA implementation.
- Completed 12 full new system validations in 2022 including large scale process equipment and enterprise server software (Vaisala viewLinc) with 60+ associated data loggers for refrigerator/freezer monitoring.
- Reduced facility and engineering open deviations by 80% in 4 months by writing and submitting 32 deviations.
Quality Engineer II
AmbioPharm, Inc
North Augusta, SC
05.2021 - 12.2022
- Reviewed all process and analytical equipment qualifications and calibrations.
- Managed site equipment compliance.
- Facilitated and drafted protocols for room and site shutdowns.
- Reviewed all deviations related to equipment, utilities and software.
- Performed internal audits.
- Aid in customer audits.
Quality Assurance Associate II
AmbioPharm, Inc
North Augusta, SC
12.2019 - 05.2021
- Performed line clearances as well as on the floor auditing.
- Reviewed process and analytical equipment qualifications and calibrations.
- Reviewed and dispositioned raw materials for use.
- Reviewed Batch Production Records.
- Responsible for all environmental monitoring data review and HVAC data trending.
- Writing QA deviations.
Quality Assurance Associate I
AmbioPharm, Inc
North Augusta, SC
05.2018 - 12.2019
- Responsible for the review of the site purified water data review as well as all HVAC data trending and review.
- Review of environmental monitoring data for all site cleanrooms.
- Review of all site environmentally controlled chamber chart recorder data.
Education
Bachelor of Science - Biology
Augusta University
Augusta, Ga12-2016
Skills
- New Asset Validation
- QMS and CMMS Administration
- Root Cause Analysis
- 21CFR Part 11 / GAMP 5
- GxP Software Compliance/Administration
- Quality Operations Compliance
- Auditing (Vendor and Internal)
- 21CFR Parts 210/211
- Technical Writing
- Project Management
- Creation of SOPs
- CAPA Management
- Microsoft Suite (Excel, Word, PowerPoint, Projects)
- Deviation and CAPA Completion and Review
- ICH Q7/Q9
- Deviation Management
Accomplishments
- Served in the back room of two successful regulatory GMP inspections by the FDA and Health Canada.
- Recipient of the 2025 Encouragement Award for performance excellence.
- Achieved site CAPA reduction through closing over 20 CAPAs in 12 months.
- Achieved chamber monitoring compliance by sourcing, validating, and implementing new Vaisala RFL100 Data Loggers with the 21CFR Part 11 compliant AP10a Access Points, and viewLinc server.
- Achieved site software compliance by executing 21CFR Part 11 assessment for all GxP software on site, identifying gaps, and addressing each gap.
Timeline
Validation Engineer Supervisor
AmbioPharm, Inc
05.2026 - Current
Sr. Validation Engineer
AmbioPharm, Inc
09.2023 - 05.2026
Associate Manager of Quality Assurance Operations
AmbioPharm, Inc
02.2023 - 09.2023
Validation Engineer
AmbioPharm, Inc
01.2022 - 02.2023
Quality Engineer II
AmbioPharm, Inc
05.2021 - 12.2022
Quality Assurance Associate II
AmbioPharm, Inc
12.2019 - 05.2021
Quality Assurance Associate I
AmbioPharm, Inc
05.2018 - 12.2019
Bachelor of Science - Biology
Augusta University