Emmanuel Velez Brito

About Emmanuel Velez Brito

Multidisciplinary engineer with a broad background in different regulated environments (GMP/GSP), and expertise in process validation and tech transfers. Strong management, analytical, planning, compliance and forecasting skills. Experience in Pharmaceutical\'s Small and Large molecule technologies.

Experience

1. Qa Validation Sr Manager

   Regeneron

   Sep 2024 — Present · Rensselaer, NY, US

   Lead and manage the QA Validation team, providing guidance, mentorship, and support to ensure high performance and professional development- Oversee the development, implementation, and maintenance of validation policies, procedures, and protocols to ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GLP, GCP)- Ensure the timely and accurate execution of validation activities, including equipment, process, cleaning, and computer system validations- Collaborate with cross-functional teams, including Manufacturing, Engineering, Utilities, and Regulatory Affairs, to ensure validation activities are aligned with project timelines and business objectives- Review and approve validation documentation, including validation plans, protocols, reports, and risk assessments- Lead investigations and root cause analyses for validation-related deviations, non-conformances, and CAPAs (Corrective and Preventive Actions)- Stay current with industry trends, regulatory changes, and best practices in validation to ensure continuous improvement and compliance- Represent the QA Validation function during regulatory inspections and audits, providing expertise and support as needed- Develop and manage the QA Validation budget, ensuring efficient use of resources and adherence to financial targets- Drive the implementation of new validation technologies and methodologies to enhance efficiency and effectiveness- Oversight the initial qualification of Fill Finish, Packaging and Device Assembly equipment.

Education

• University of Puerto Rico-Mayaguez

  Bachelor's degree, Chemical Engineering

  2009 — 2016

Skills

• Project Management
• Analytical Chemistry
• Teamwork
• Nanocomposites
• Electrospray
• Characterization
• Spectroscopy
• Materials Science
• Organic Chemistry
• Plastic Extrusion
• Matlab
• Capa
• Polymers
• Research
• Mathcad
• Trackwise
• Extrusion Coating
• Pharmaceutical Engineering
• Scanning Electron Microscopy
• Nanomaterials
• Ir
• Nanotechnology
• Granulation
• Chemistry
• Polymer Science
• Uv/Vis
• Group Work
• Minitab
• Chemical Engineering
• Coatings
• Microsoft Office
• Nmr
• Validation
• Manufacturing
• Cpv
• Engineering
• Nanoparticles
• Polymer Characterization
• Compression Molding
• Leaching