01
Lead validation planning and execution for critical clean-utility and facility systems, including WFI, compressed air, and HVAC/AHU systems.
Project 02IPS / BWXT Medical
$10M+ Radiopharmaceutical Manufacturing Program
Leading CQV strategy and execution inside an active GMP radiopharmaceutical manufacturing facility supporting isotope-based medical products.
The problem
How do you make critical manufacturing infrastructure ready for regulated production?
Approach
Risk-based validation planning and execution across engineering, QA, automation, facilities, manufacturing, schedules, risk, and technical documentation.
Outcome
Supporting clean-utility readiness, facility expansion, new drug line introduction, and compliant system turnover within an active GMP environment.
What I led and delivered
02
Apply ASTM E2500 risk-based validation principles, FMEAs, impact assessments, and traceability to optimize scope while maintaining GMP compliance.
03
Coordinate WFI shutdowns, maintenance activities, restart validation, P&ID walkdowns, component verification, functional testing, FAT/SAT, and structured turnover to operations.
04
Manage deviation investigations, root-cause analysis, and CAPA implementation to support audit readiness and regulatory compliance.
05
Drive integrated schedules, action registers, risk and issue tracking, stakeholder reporting, escalation, and technical documentation across concurrent workstreams.
Demonstrates
Regulated execution · cross-functional leadership · delivery discipline