Justin Nadeau

Engineering Contractor @Boehringer Ingelheim

Livermore, CA, US
MOBILE NUMBERS
+13•••••••08

Signup · Get unlimited contacts

WORK HISTORY

Dec 2024 — Present

Engineering Contractor @Boehringer Ingelheim

View department →

EDUCATION

1992 — 1996

University of Connecticut

BS, Ecology and Evolution

SKILLS

Change ControlGxpGmpQuality SystemV&VBiotechnologyPharmaceutical IndustrySopFdaGlpQuality AssuranceMedical DevicesCapaManufacturingTechnology Transfer21 Cfr Part 11Life SciencesCross-Functional Team LeadershipBiopharmaceuticalsValidation

ABOUT JUSTIN NADEAU

Independent consultant with 25+ years of experience in the biotech, pharmaceutical, and medical device industries. Specializes in GMP manufacturing, validation, engineering, facilities, and quality assurance. Proven track record in commissioning/qualification of equipment/utilities, lifecycle documentation, CAPA/deviation management, and regulatory compliance. Adept at leading cross-functional teams, optimizing quality systems, and supporting successful FDA/EMA inspections.Core Competencies• Validation & Qualification: Manufacturing Equipment, QC Equipment, Utilities, Facilities, EMPQ, Process, Cleaning, Irradiation, FAT/SAT• Quality Systems: CAPA, Deviations, Change Control, OOT/OOs Investigations• Engineering & Facilities: Asset Onboarding (CMMS), Work Order Administration, Calibration/PM, Commissioning, Front Line Support• Documentation & Compliance: Risk Assessments, Lifecycle Docs, Technical Writing, Audit Support, Training, Periodic Reviews, SOP Development

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.