Brian D. White Email & Phone Number

Hillerød, Capital Region, Denmark

As a Tech Transfer Lead and SME within the Validation Downstream sub-department at FDBD, my primary responsibility is to assess changes that are associated with introducing new products to the site, and to ensure that the validated state of FUE (Facilities, Utilities & Equipment) is maintained at all times.This involves meeting with various stakeholders several times per day, assessing potential risks, identifying which activities are required, planning/coordinating activities, executing activities, and analyzing/reporting the data.The main areas of validation that I focus on are: FUE Qualification (IQ, OQ, and PQ), Cleaning Validation (Cleaning Agent/Soil Removal), DHT and CHT Studies (Dirty/Clean Hold Time), Mixing Validation, Microbial Hold Studies, and more.Some of my other duties include writing SOPs (Standard Operating Procedures), TDs (Technical Documents), TRs (Technical Reports), VPPs (Validation Project Plans), VFRs (Validation Final Reports), Validation Protocols, Deviations/Investigations, CAPAs, and much more.I am also involved in several ad-hoc projects at FDBD, as it is very important to me to keep learning and developing.

County Limerick, Ireland

As part of the Cleaning Validation sub-department, my team was responsible for the coordination of clean hold studies. The primary purpose of this role was to show that the system for establishing the expiry of clean equipment was in a state of control.The equipment of interest included bioreactors, vessels, transfer panels and lines, chromatography skids and more. These studies involved collaborating with various stakeholders to discuss complex information and schedule activities. Some of the key duties included:• Technical Writing – Writing and peer reviewing protocols, summary reports and deviation reports. Process maps, P&ID flow-paths and other visual aids were also developed to support documentation.• Study Execution – Verifications such as equipment qualification and calibration status etc. were carried out prior to study execution. Gowning to the ISO 8 cleanroom standard was required. Execution involved rinse and swab sampling, visual inspection and any other duties outlined in the relevant protocols.• Problem Solving – Troubleshooting and root cause analysis were used to identify the source of deviations or failures. Risk assessment was then used to evaluate the level of impact, influencing potential solutions.

Dublin, Ireland

Focused on three key different areas of Validation: Process, Cleaning and Equipment Qualification. Theory focused on areas such as, VMP, validation strategies and the process validation lifecycle.• Cleaning Validation – Developed cleaning validation reports, sampling plans and SOPs. Developed an understanding of the principles of a matrix approach in cleaning validation. • Equipment Qualification – Generated IQ, OQ and PQ protocols and executed IOQ protocols. Developed a PQ report for purified water system.• Change Control /CAPA – Carried out a change control study for change of an equipment for an OSD process. Developed a change control report for the study. Gained experience in analysis impact assessment with regards to change control. Investigated deviations/non-conformances and identified appropriate CAPAs to put in place.

8000 Aarhus C, Denmark

8000 Aarhus C, Denmark

8000 Aarhus C, Denmark

Melbourne, Australia

Melbourne, Australia

Whoroughly, Vic, Australia

Perth, Australia

Perth, Australia

Greater Chicago Area

County Limerick, Ireland

County Limerick, Ireland

Greater Chicago Area

County Limerick, Ireland

Diploma, Professional Competence, 2.1

Self-Awareness, Communication, Teamwork, Motivation, Project Management, Presentation Skills, Leadership, Performance Management, Time.

L8 Certificate, Quality Engineering, 2.1

Statistics, Management and Leadership, Quality Systems, Probability Theory, Discrete Distributions, Continuous Distributions, Product.

Bachelor Of Science - Bs, Medicinal And Pharmaceutical Chemistry, 2.1

Activities and Societies: - Founder of LIT Surfing Society - Entertainments and Events Officer, LIT Students Union (1 year) - Clubs.

Green Belt, Lean Six Sigma, Distinction