Kevin Hall

About Kevin Hall

Multi-faceted process engineering professional experienced in executing and managing process improvement, technical transfer, manufacturing support, and product development projects in the regulated medical device and pharmaceutical industries• Commercialized and transferred numerous medical device, pharmaceutical and OTC products• Significant track record of process and product improvement in regulated environments• Situational analysis making insightful data-driven decisions• Advanced Certificate in Applied Statistical Methods• Skilled with managing multiple projects and initiatives in a dynamic environment• Well-developed communication and technical writing capabilityProficiencies and Technical Skills: Manufacturing Engineering & Support; Product Development, Technology Transfer and Scale-Up; applied statistical methods; data visualization using Tableau; process modeling; design of experiments (DOE); facility design, construction, and qualification; contract manufacturing; ophthalmic medical device solutions; OTC Pharmaceutical drops; aseptic filling & manufacturing; blow / form-fill-seal aseptic filling (BFS / FFS) with Weiler and Romelag equipment; sterilization processes; filtration system qualifications; bulk heat sterilization; production steam autoclaves; validation; manufacturing information systems; LIMS implementation; design control & documentation; master production records / formulation bills of materials; ISO-13485; 21 CFR 820; 21 CFR 210 & 211

Experience

1. Sr Principal Process Engineer, Primary Packaging & Mdcp Products, Site Technical Services, Pgs

   Pfizer

   Sep 2016 — Present · McPherson, KS, US

   Site SME for Visual Inspection Defect Monitoring control limit setting process and data analysis; Team lead for primary packaging engineers; process owner for Manufacturing and Packaging accountability & yield control limit setting; product chemical quality prediction modeling and control limit setting; experimental design and analysis. Contributed to significant process improvement in statistical sampling, defect limit setting, data gathering, and rigorous analysis of manufacturing data for Quality Manufacturing Investigations. Implemented first-in-company visual inspection defect dashboard visualisation using Tableau.Led project team implementing standardised ISO 2 mL vial geometry to improve site operations, simplification of sourcing, and reduction in unit costs for multiple biological and small molecule SVP products. Responsible for supporting device-combination product documentation lifecycle maintenance including management of pFMEA, process flows, and control plans. Including improvements to cartridge product EPR performance, reduced part count in needle hub assembly, and use of post-consumer content PET clamshell packaging. Autoclave Process Remediation workstream lead for Equipment Prep process improvement including fixtures, packaging, and orientation (9 mos split-assignment).

Education

• Rochester Institute of Technology

  Advanced Certificate in Statistical Methods for Product and Process Improvement, Applied Statistics

  2010 — 2014

• Rochester Institute of Technology

  Bachelor of Science (BS), Packaging Science, Engineering Option

  1982 — 1987

Skills

• Quality Assurance
• Process Engineering
• R&D
• Software Documentation
• Root Cause Analysis
• Design of Experiments
• Manufacturing
• Commercialization
• Iso 13485
• Validation
• Product Development
• Technology Transfer
• 21 Cfr Part 11
• Sterilization
• New Business Development
• Statistics
• Otc
• Statistical Tools
• Process Improvement
• Medical Devices
• Capa
• Technical Writing
• Minitab
• Change Control
• Dmaic
• Manufacturing Engineering
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Quality System
• V&V
• Process Simulation
• Lims
• Quality Control
• Gmp
• Six Sigma
• Aseptic Processing
• Design Control
• Chemistry