Justin Nadeau
Validation and QA Consultant
- Role
- Engineering Contractor at Boehringer Ingelheim
- Location
- Livermore, CA, US
- LinkedIn followers
- 500 followers
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
Experience
Engineering Contractor
Dec 2024 — Present
Education
University of Connecticut
BS, Ecology and Evolution
1992 — 1996
Skills
- Change Control
- Gxp
- Gmp
- Quality System
- V&V
- Biotechnology
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Quality Assurance
- Medical Devices
- Capa
- Manufacturing
- Technology Transfer
- 21 Cfr Part 11
- Life Sciences
- Cross-Functional Team Leadership
- Biopharmaceuticals
- Validation
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