Brian Wardell

About Brian Wardell

Previous ASQ Certified Software Quality Engineer with deep knowledge and experience in all aspects of Quality Assurance, including corporate-wide computer system validation.Specialties: Successfully validated and launched large, multi-site, corporate-wide computer systems. Seasoned professional at Quality Assurance, Manufacturing, system and equipment validation, data integrity, deviation management, regulatory inspections (FDA, EMA, ANVISA [Brazil], Health Canada, South Korea, Turkey MOH, Belarus, COFEPRIS [Mexico], and Russia), drug product plant start-up, lean production system, and working cross-functionally to improve processes, drive efficiency and deliver results.

Experience

1. Principal Quality Engineer

   Genentech

   Oct 2024 — Present · Hillsboro, OR, US

   Provide Quality oversight and ensure compliance of the validation, maintenance, and change control activities for automation systems and utilities/facilities at Genentech\'s Hillsboro, Oregon Fill and Finish facility. Quality Engineering Validation lead for our Manufacturing Execution System, Building Automation System, Information Management System, Process Control System, SCADA system, and new Modular Filling project. Continuously driving process improvements to our Qualification business practices, engage in the creation of strong cross functional synergies and communication, and represent QEV on network wide teams and initiatives.

Education

• Tulane University

  BS, Biology

  1984 — 1988

Skills

• Multi-Site
• Computer System Validation
• Quality Assurance
• Change Control
• Mes
• 21 Cfr Part 11
• Cgmp
• Biotechnology
• Biopharmaceuticals
• Risk Based Validation
• Continuous Improvement
• Protein Purification
• Aseptic Processing
• Gmp
• Validation
• Quality Management
• Gamp
• Fda
• Cross-Functional Team Leadership
• Quality Auditing
• Lims
• Capa
• Trackwise
• Sop
• Glp
• Technology Transfer
• Cleaning Validation
• Quality System
• Good Laboratory Practice (Glp)