Robert Reid
Kilkenny
Summary
Validation engineer with over six years of experience in the pharmaceutical industry. Skilled in equipment qualification (DQ, IQ, OQ, PQ), cleaning validation, and troubleshooting complex issues across cross-functional teams. Lean Six Sigma Black Belt certified, with a strong track record in continuous improvement, CAPA implementation, and supporting both greenfield start-ups and established manufacturing operations. Adept at collaborating with automation, quality, and operations stakeholders to ensure compliance, efficiency, and high-quality execution in GMP environments.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Validation Engineer III
FUJIFILM Diosynth Biotechnologies
Hillerod
10.2024 - Current
- Led the successful execution of the first Validation Product Process Qualification (PPQ) campaign at a newly built pharmaceutical facility. Ensured full compliance with regulatory and quality standards while coordinating cross-functional teams to support commercial readiness
- Played a key role in commissioning and qualification (C&Q) activities during facility start-up, contributing to DQ, IQ, OQ, and PQ phases and ensuring compliance with GMP and project timelines
- Acted as a (SME) during customer and regulatory inspections, delivering clear technical justifications and validation summaries
- Led qualification activities, including Cleaning Validation, Sterility Hold, SIP, Mixing, and Clean Hold, as part of the equipment qualification program at a greenfield pharmaceutical facility
Validation Engineer II
FUJIFILM Diosynth Biotechnologies
Hillerod
07.2023 - 10.2024
- Thrived in a fast-paced CDMO environment, managing multiple validation projects across several customers and products simultaneously. Liaised directly with clients to align on validation strategy, timelines, and deliverables, ensuring high-quality outcomes under tight manufacturing schedules
- Led cross-functional investigations, identified root causes, and delivered successful CAPAs to prevent recurrence and maintain regulatory standards
- Mentored new engineers and operators, aligning with site capability-building goals, and supporting accelerated team ramp-up
- Led site-wide Lean projects: Reduced validation protocol approval time by 15%, and initiated a utility-focused sustainability project targeting a 10% reduction in water usage
QA Validation Specialist
Regeneron
Limerick
11.2022 - 01.2023
- Led cleaning validation projects, both initial and ongoing cleaning validation activities for specific products. Served as a Subject Matter Expert (SME) for the clean-hold validation program across QA Validation and Operations. Achieved extended clean-hold times, reduced verification sampling requirements, and decreased labor costs
- Gained expertise in drafting and reviewing validation protocols, summary reports, risk assessments, SOPs, deviations, exceptions, and other technical documents
- Delivered two key continuous improvement solutions: redesigned the protocol summary report template through cross-site collaboration, increasing right-first-time report generation by 15%, and restructured validation work areas, resulting in a 50% increase in usable workspace
Associate QA Validation Specialist
Regeneron
Limerick
06.2020 - 11.2022
- Served as Department Safety Officer, leading to a 10% increase in hazard identifications by team members. Presented safety performance updates and findings during both site-wide and departmental meetings
- Gained hands-on experience with manufacturing systems and equipment during validation execution, including P&ID walkdowns, HMI interface operation, and functional testing alongside automation and maintenance teams
Education
Bachelor of Science - Industrial Biochemistry
University of Limerick
Limerick, Ireland05-2020
Skills
- New Facility Start-Up and Operational Readiness
- Commissioning and Qualification (C&Q) – DQ, IQ, OQ, PQ lifecycle
- Equipment Qualification – SIP, Mixing, Sterility Hold, Clean Hold
- Process Validation and Cleaning Validation
- Root Cause Analysis and CAPA Implementation
- Regulatory Inspection Support – SME-level experience
- Deviation Investigation and GMP Documentation
- Continuous Improvement Tools – 5S, DMAIC, A3, and Kaizen
- Team coaching and capability development
- Cross-Functional Project Leadership
Additional Experience
- QA Validation Intern - Regeneron, Jan 2019 - Aug 2019, Limerick, Ireland
Certification
- Lean Six Sigma Black Belt – The Knowledge Academy
- Lean Six Sigma Green Belt – The Knowledge Academy
- Lean Six Sigma Yellow Belt – The Knowledge Academy
Technical Skills
- Software: Veeva, TrackWise, DeltaV, Microsoft Project, Excel, Pi Explorer
- Methodologies: DMAIC, Root Cause Analysis, 5 Whys, Fishbone Diagrams
- Systems: GMP, FDA/EU Annex 15, ICH Q8–Q10
References
References available upon request.
Timeline
Validation Engineer III
FUJIFILM Diosynth Biotechnologies
10.2024 - Current
Validation Engineer II
FUJIFILM Diosynth Biotechnologies
07.2023 - 10.2024
QA Validation Specialist
Regeneron
11.2022 - 01.2023
Associate QA Validation Specialist
Regeneron
06.2020 - 11.2022
Bachelor of Science - Industrial Biochemistry
University of Limerick
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