Los Angeles Metropolitan Area
Commissioning, validation, engineering, construction, maintenance, and procurement for the building of new and modifications of existing Biotech/Pharmaceutical/ and Medical Device facilities.
Technical Interface between Client, "Roche-Genentech", General Contractor- DPR, Weld Inspection Company, QAM, and Mechanical Contractor Murray for smooth transition of Welding ISO drawings to be submitted to GDP Turnover Packages (TOPs).
Quality events included Change Control, Deviations, CAPAs, and periodic reviews. Audit Trails of Cell Counter Instrumentation were sent to me from the talented IT Team that were reviewed and approved with comments for continuous process improvements. Reviewed and Approved executed Protocols for on-site assets that included Liquid Nitrogen Freezers, Freezers, Refrigerators, and CO2 Incubators. Supported Quality Validation Team on Controlled Temperature Chambers’ Open Door and Power Loss CAPA studies. State of the Art Software was used for seamlessly managed quality process and content. Software as a Service (SaaS) designed exclusively for the life sciences industry was used for the maintenance management, calibration management, and asset management for a combined software package with a robust single solution. Introduced the IT Team to the most current ISPE GAMP guidelines used for site-wide documentation updates. Quality Periodic Reviews of T-Cells Process Instruments (Cell Counters (Cellometers), Cytometers, etc.) Quality Periodic Review of Facility’s SIEMENS Environmental Monitoring System (EMS) Quality Periodic Review of Laboratory Information Systems Labware (LIMS) Software System Quality Periodic Review of JPM Statistical Software and Continuous Particulate Monitoring (CPM).
VMP generation for California Manufacturer of cell culture media and supplements. The Manufacturer provides reagents that enable the discovery, development, and production of biopharmaceutical products such as drug therapies, novel vaccines, and molecular diagnostics. The company's product offerings include pre-poured media plates for cell growth and cloning, liquid cell culture media and supplements for cellular expansion, and molecular biology reagents for sample manipulation, resuspension, and purification. Also worked on Engineering Studies for Cryogenic Freezers remotely for a different client in Indianapolis, Indiana.
Worked as a Team player on the Covid 19 mRNA-lipid nanoparticle (LNP) and tangential flow filtration (TFF) COVID-19 vaccine projects. Provided experienced decision making to less experienced Team members. Interfaced with the Automation Team and Software Developers following Good Automation Manufacturing Procedures (GAMP) guidelines for the Site Acceptance Testing (SAT), Functional Specification (FS), and Design Specification (DS), with generating punch lists of observations on any differences. The Software Systems involvement included Utilities, Main PLC, and Batch SCADA systems. Verification Testing was also executed with Non-Conformances written against any issues that did not meet the established acceptance criteria. Systems execution performed on included CIP System, Bag Lifts, Pump Carts, and Tank SCADA. Software Equipment Modules were found partially completed as well as missing by the Automation Engineers who were relentless for quality continuous improvement of the custom software being written for the project.