Glenn Smith

Background

About Glenn Smith

An accomplished and motivated leader with a solid foundation supporting the Pharmaceutical, Life Sciences, and Biotechnology Industries. I leverage my progressive career, extensive experience, and strong mechanical aptitude to design and drive turn-key continuous improvement initiatives supporting Manufacturing, Engineering, Facility/Utility Systems, Plant Operations, Commissioning & Qualification, and Quality Compliance standards. My skills allow for creatively defining and integrating solutions by combining strategic thinking with an eye for detail. I leverage my expertise to lead and drive Projects delivering effective results necessary to meet corporate goals and quality standards. I possess a track record of success in mentoring, coaching and training, sharing my vast experiences and knowledge to optimize skills, developing high performing teams of professional engineers, trades, contractors, and operators while building great relationships. I develop presentations, workshops, and other training curriculums supporting ongoing growth in a regulated and complex environment. I've successfully led multiple projects, designing and implementing new technologies, methodologies, policies and procedures establishing best-in-class practices improving operations & quality standards to support business demands and regulatory requirements. Core Competencies and Hard Skills:* Pharmaceutical Standards - cGMP 21 CFR Part 11/Quality Systems * Regulatory Inspections - HPFBI/FDA/EU/TSSA/MOE * Engineering/Manufacturing Best Practices * Audit and Identify Performance Gaps - Analysis, Measure, Action * Commissioning, Qualification, & Validation - Equipment, Utility, & Facility * Construction & Installation - Expansion, restoration, & start-up projects * Continuous Improvements - Facility/Equipment upgrades * Facility/Utility Systems - Design & certification requirements * Vendor/Contractor Management - Negotiate MSA's driving cost reduction * Operational/Reliability Excellence - Maximize Utilization/Production Stability * Maintenance Strategies - Optimizing equipment/utility design and utilization * Reliability-centered Maintenance - Determine & improve maintenance requirement * Key Performance Indicators (KPI)- Develop and analysis * Total Production Maintenance (TPM)- Maximize equipment effectiveness/Operator involvement * Enterprise Asset Management Systems (EAM/CMMS)- Design and implementation * Building Automation Systems - Supporting GMP environmental conditions * Lean Manufacturing - OEE/changeover reduction/eliminate waste/5S