Kyle Warner
CSV & QA Validation Engineer | GAMP 5 | PAS-X | SAP | TrackWise | 21 CFR Part 11 | Biopharma Compliance | Kneat | CSA | MES Systems
- Role
- Automation Engineer Ii at Flexware Innovation
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Kyle Warner
CSV & QA Project Consultant in Biopharma | GAMP 5 | 21 CFR Part 11 | PAS-X | SAP |…
Experience
Automation Engineer Ii
Apr 2022 — Present · Holly Springs, NC, US
Contracted to Fujifilm CDMO – Holly Springs, NC1. QA Project Manager (Apr 2022 – Apr 2023):Drove QA-side implementation planning for Fujifilm site startup, including workforce development, tier board dashboards, SOP onboarding structure, Smartsheet project coordination, and college partnership initiatives. Developed internal systems for department organization and team-building.2. CSV/QA Validation Engineer (Apr 2023 – Sep 2024):Led QA validation activities for key GMP systems including TrackWise, SAP, and XpertLog, reviewing and approving full CSV documentation packages with a focus on data integrity, GAMP 5, and regulatory readiness. Coordinated UAT execution and internal alignment across QA and IT.3. Automation CSV Engineer (Sep 2024 – Present):Leading validation efforts for the PAS-X MES, Octoplant, and Siemens BMS (AVEVA/PLC) systems. Authored full validation lifecycle documentation in Kneat, executed test protocols (IQ, OQ, SIV, SAT, RTM), and trained SMEs on compliance execution. Ensured audit readiness and electronic records control per 21 CFR Part 11, Annex 11, and CSA.
Education
Northern Virginia Community College
Associate of Science (A.S.), Biomedical/Medical Engineering
2015 — 2017
Virginia Commonwealth University
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2017 — 2020
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