Michael Bozza Email & Phone Number

Billerica, Ma, Us

Billerica, Ma, Us

• Responsibilities include:• Participation in Design of Experiments (DOEs) on new product process window• Participation in new product Failure Mode & Effects Analysis (FMEAs)• Creating Operational Qualification (OQ) protocols outlining new product validation testing based on New Product Design Specifications (NPDS)• Data collection & analysis of validation tests using MiniTab & Microsoft Excel• Test method & test equipment troubleshooting (mechanical & system errors)• Writing Operational Qualification (OQ) reports including validation test summaries & analysis• Analyzing capability of new product in-process testing (Cpk, Ppk)• Responsible for documenting and improving various test methods and standard operating procedures for the VAC.• Developed an improved test method for VAC’s fiber releasing test

• Performed general tests for various filter cartridges. Testing included: air integrity; reverse bubble and bubble points; hydraulic and stress profiles; high temperature and pressure exposure interpretation.• Responsible for recording and organizing data collected with carbon filter testing. Familiar with TOC (total organic carbon) meter for the calculation of percent retention. SDI (silt density index) testing of water systems such as DI, UF, and RO filtration apparatus.• Responsible for data generation and results interpretation, and reporting of collected data to related departments.• Constructed apparatus to conduct proper testing on cartridges.• Familiar with normal and tangential flow membrane filtration methods.• Data collection and entry

• Performed analysis on candidate formulations for new COPD drug, which included: Fine Particle Fraction using an Andersen Cascade Impactor, Emitted Powder Mass, and Particle Size Distributions using a RODOS Laser system.• Responsible for recording and organizing data for use in candidate formulation selection reports.