Justin Nadeau
Engineering Contractor @Boehringer Ingelheim
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WORK HISTORY
Engineering Contractor @Boehringer Ingelheim
EDUCATION
University of Connecticut
BS, Ecology and Evolution
SKILLS
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
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