Julien Boukhaled Email & Phone Number

Professional Consultant in the pharmaceutical and biotechnology industry with a Bachelor of Applied Science (B.A.Sc.) focused in Chemical Engineering, and 8+ years of hands-on experience with production equipment and cleaning/process validation in GMP facilities.Demonstrated knowledge and application of lifecycle- and risk-based Process Validation principles using a Quality by Design framework, in compliance with regulatory requirements/guidelines (FDA, PDA, ICH, Health Canada) and cGMP standards.Quality Assurance SME in Validation services and Quality Management Systems, providing professional training, guidance, strategy and execution for large-scale capital projects, Quality Risk Register remediation work as well as regulatory submissions, and supporting Clients in securing and maintaining pharmaceutical product licensing.Experienced team player, Lean Six Sigma enthusiast, and avid language learner.

Listed skills include Gmp, Sap, Lims, Teamwork, and 11 others.