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EMAIL AVAILABLE (primary) EMAIL AVAILABLE (secondary) Tel. No.: PHONE NUMBER AVAILABLEGENERAL PROFILE, KNOWLEDGE & LEADERSHIP (USA & OFF-SHORE)Engineering, Design & Design Improvement, Construction of Manufacturing Facilities, DAT, SAT, FAT, GMP Equipment Systems, Utilities (Clean, GMP), Aseptic & Sterile Filling Manufacturing Facilities (includes Packaging Validation per ISO 11607, Form/Fill/Seal Systems & Primary, Secondary, Tertiary Packaging (SVP/LVP & Med Devices), knowledge of QBD & DOE.Process Validation, Compliance and Remediation, CQV, Integrated Commissioning & Qualification [risk-based qualification ASTM E2500] for equipment, facilities and utilities (Clean & Plant)].Validation Master Plans [based on URS, Gap, Risk & Calibration Risk Assessments, Audits, Impact Assessment, FMEA/FMECA]. Engineering Change Management, Continuous & Continued Verification activities. Process Validation Projects (PPQ).Clean Rooms (ISO Class 1, 4, 5, 6, 7; includes Qualification, Certification, Design, HVAC Systems Construction & Initial, Retro, Re-Commissioning, TAB, Inspection, Maintenance).Qualification for Equipment, Facilities, (RO/DI, WFI Systems, Clean Steam, Clean Compressed Gasses, Clean Room Systems & Clean Room HVAC, CIP & SIP Systems. Validation Document, URS, FRS, IQ, OQ and PQ protocols, traceability matrices.Risk-Management for Risk-Based Validation. New products RA to the facility, Cleaning and Sterilization Validation Requirements.Cleaning Validation Projects for residues that affects form, fit, function, sterility and safety [API, Chemical, Viable and Non-Viable Particulates] and contaminants produced in manufacturing. Assessments of potential contaminants and establishing Residue Limits/MACO/PDE (Dosed-Based, PPM-Criterion, Toxicity-Based, EMAs Health-Based Cleaning Limits (PDE).Cleaning Process Development (Measurement of Cleanliness, Residuals Identification, Optimum Cleaning Method) to clean product and contact surfaces. Identification of chemicals, components from outside sources potentially remaining during manufacturing, and product contact surface areas calculations.Sterilization process development and validation of Autoclaves, Sterile In Place (SIP), ETO, VHP (for Isolator Systems).Engineering and validation assistance for Drug-Device Combination Products and Medical Devices based on QSR, 21 CFR Part 820. Assessment of the design during development and resolving deficiencies of the design.Critical Systems [WFI, RODI, USP Purified Water, Clean Steam, Clean Compressed Gasses (Argon, Oxygen, Helium, Nitrogen, Clean Compressed Air], Equipment, Piping and Process Systems meeting cGMP, GDP, GEP, GXP, 21 CFR 820 Parts 11, 210/211, 600/601/610, 21 CFR Part 820 (QSR), ISO 13485 (Medical Devices Quality), ICH Q7 Requirements.Process Flow Diagrams (includes quantitative), P&ID, Equipment & User Requirements Specifications (URS). Knowledge of Unit Operations, Mass Balances, Heat Transfers, Lyophilization (IMA, Hull, Virtis, Steris) Fluid Bed Drying, Centrifugation, Chromatography Columns, Filtration, CIP & SIP, Sterilization (Steam, ETO, Electron Beam, Gamma, VHP, De-Pyrogenation).Engineering for Non-GMP Utilities (City, Hot & Chilled Water, Boilers, Cooling Towers, Steam, Freezers, Refrigerators, Dryers.Managed A/E Contractors, Project, Process, Plant and Facilities Engineering. Process Characterization and Improvements, Process Scale Up, Technology Transfers, Automation/Mechanization.EDUCATIONAL ATTAINMENTB.S. in Chemical Engineering Far Eastern University, Manila, PhilippinesCourses in Clinical Applications of Biomedical Engineering and Cardiovascular Physiology UC Irvine, CARecent Training & Industry Related CoursesChange Control Management, Principles of Auditing, FDA Tour, FDA QSR/ISO 13485:2016 QMS For Medical Devices, Lifecycle Approach to Cleaning and Process Validation, Conference Speaker IVT Lab Week December 2019 Philadelphia, PAIVT Cleaning Validation Philadelphia PA 2019, ASTM E2500 - Risk-based Approach to Commissioning and QualificationPDA TR. No. 1 2007 Validation of Moist Heat Sterilization Processes & PDA TR No.61 Steam In Place 2013Project Management (Franklin Covey), Process Quality Control and SPC, Validation of Process Control SystemsProcess & Software Validation, Lean Manufacturing and Six Sigma/DMAIC, Steam Sterilizer Validation Per ISO 17665Refresher Courses for 21 CFR Part 11, 210, 211, 820, Analytical Instrument Qualification & System ValidationPROFESSIONAL EXPERIENCEPrincipal Engineering Consultant PSE LLC Harpers Ferry, WV January 2024 To DateCurrent Project: CQV Plans and Strategies encompassing:- Schedule and resource plans for project stages deliverables.- C&Q Plan per Validation Master Plan (VMP). Oversight of C&Q SIA, Risk Assessments, Vendor Assessment and others.- C&Q/CSV resources management (personnel, documentation, test equipment) to complete C&Q/CSV.- Systems transition from MEP (Mechanical Electrical Plumbing) completion to start-up.- Completion of project C&Q documentation (i.e.: protocols, TOP, manuals, others).- Reviews before system power up.- Live System operational tests during C&Q phase.- Implementation of the Stakeholder SHE Requirements for risks during start-up, commissioning and qualification.- Manage C&Q/CSV resources (personnel, documentation, test equipment) to complete project execution.- Training for C&Q resources are completed.- Acceptance of systems and construction TOPs at MEP completion- Approvals of commissioning and qualification protocol results, raw data calculations, and completed test scripts per established acceptance criteria, standards, processes and procedures.- Review and approval of FAT and SAT completion and documentation.- System calibration and tuning, monthly Project Progress Report.- Commissioning and Qualification Preliminary Design Review Board (PDR) of system power up, commissioning, qualification.- Resolution of Type: A (show stopper), B (must be solved prior to turnover), C (minor defects, to be resolved after handover) deficiencies. Manage deviation closeout process during C&Q phase.- Handover post commissioning and qualification to Client.Senior Manager Engineering & Equipment Cellphire Therapeutics Rockville, MD Jan 2023 to Feb 2024Allogeneic Cellular Therapeutics that harness the inherent biological capabilities of human cells. The therapeutic platform consists of three technological capabilities. Th lead product is Thrombosomes, led to a host of novel cellular therapies.-Stabilization of Human Cells for extended shelf life with rapid restoration, easy preparation and use.-Pooling Human Cells from many Donors ensuring consistent quality, safety, and scalable production.- Formulating Cell Therapies to achieve a desired biological outcome.Engineering and validation support of Manufacturing and QC operations equipment management (for Manufacturing Facilities, Systems, Instrumentation, Computer Systems, Maintenance, Calibration, Upgrades), implementation of LIMS (Labware) Equipment Management, installation of new Capital Assets, Facilities, Equipment Qualification, Process Validation, Cleaning Validation, CSV, Spreadsheet Validation. Assists on capital expenditure budgets to support manufacturing operations. Review and trend performance of critical GMP equipment and equipment lifecycle.Engineering Fellow Catalent Gene Therapy Gaithersburg & Rockville, MD Sites Biotechnology Feb 2021 to Jan 2023Engineering and Validation Projects (Equipment, Utilities, Facilities, Process and Cleaning Validation) to support Client Projects and Capital Expansion Projects for New Plasmid DNA Manufacturing Suite, Manufacturing Facility Upgrades and Expansion for Catalent Gaithersburg, MD Facility (Mammalian and Viral manufacturing of drug substances via suspension and adherent cell processes for Clinical Stage Products) and Catalent Rockville, MD Facility (mammalian, microbial, viral, and plasmid products).ProjectProject ScopeDeliverables & Status1.Process and Cleaning Validation Master PlansWrite the document.Complete.2.Wave Bioreactor Systems (Single Use)IOQComplete.3.Fermenters ABEC Fermenter (Plasmid Project), Eppendorf New Brunswick Bioflo ProRisk Assessment, URS, IOQ, Cleaning Validation (Residue Identification, Residual Limits, Coupon Studies, Cleaning Recovery Studies, Cleaning Process Development, EDHT, CEHT).Eppendorf - IOQ complete, Cleaning Validation activities in progress.ABEC Retrospective URS write up, IOQ next.4.Repligen TFF SystemIOQComplete.5.Alfa Laval Stacked Disc Centrifuge, Sharples Ultra CentrifugeRisk Assessment, URS, IOQ, Cleaning Validation (Residue Identification & Limits, Coupon Studies, Cleaning Process Development & Recovery Studies, EDHT, CEHT).IOQ Complete.Cleaning Validation activities in progress.6.Sanimatic CIP SystemRisk Assessment, URS, IOQ, Cleaning Validation (Cleaning Process Development, Cleaning Recovery Studies, EDHT, CEHT).IOQ Complete. Cleaning Validation in progress. Communication between the CIP System (Cleaning Equipment) and Alfa Laval Centrifuge (Equipment to cleaned.7.MicrofluidizerIOQ. Cleaning Validation (Residue Identification, Residual Limits, Cleaning Process Development, Cleaning Recovery Studies, EDHT, CEHT).Complete. Cleaning Process Development & Recovery Studies, EDHT, CEHT in progress.8.Sharples Ultra-CentrifugeRisk Assessment, IOQComplete.9.Thermo Impulse Single Use MixerRisk Assessment, URS, IOQ.In progress.10.RODI SystemRetrospective URS & IOPQ (Legacy)Complete11.Clean Compressed Air SystemRetrospective URS, Requal IOPQ (Legacy)Complete12.Liquid Oxygen Supply SystemRetrospective URS, Addendum IOPQ (Legacy)Complete.13.Clean Steam GenerationRA, URS, CAR, Vendor Selection, IOPQ.In progress.Principal Engineering Consultant Winchester VA Pharmaceuticals Jan 2020 Feb 2021ProjectProject ScopeDeliverables & StatusIsolator System Project (Aseptically Filled Product)Engineering (URS, FRS, FAT, SAT) and Process Validation [Lifecycle Approach & Risk Management, Validation Master Plan, Equipment, Clean Utilities & Clean Room Qualification, Cleaning Validation, VHP].URS, FRS for Equipment, Clean Utilities & Clean Rooms, Validation and Cleaning Master Plans Complete.Executive Consultant PQE Group Florence, Italy Life Sciences Jan 2020 December 2020A Contract Quality Organization and Complete Quality Solution Provider for GCP, GLP, GMP & GDP areas.-Engineering and validation solutions to processes, facilities, process equipment, utilities and control system for the life science companies (i.e.: Stevenato, Takeda, Novartis, Thermo Fisher Scientific, AAA (Novartis), Livanova, Baxter and others).ProjectProject ScopeDeliverables & StatusDispensing and Visual Inspection Equipment for Radiopharmaceuticals AAA (Novartis) New Jersey, USAWrite URS, FRS and Equipment Installation Operational Performance QualificationComplete.CSI Data Integrity Assessment Baxter Canada and Thetford UKAssessment Support and GMP RemediationCompleteEO Sterilization Livanova Arvada, Colorado USASterilization Validation SupportCompleteLaboratory Stevenato Boston, MA USAQualification and Maintenance SupportCompleteSite Validation Manager Thermo Fisher Scientific Middletown, VA Medical Devices Jan 2019 - Dec 2019IVDD & Specialty Diagnostics: Diagnostic Test Kits, Reagents, Culture Media, Instruments and associated products for use in Clinical Diagnostics, Immunodiagnostics, Microbiology, Anatomical Pathology, Transplant Diagnostics and Healthcare Market. [Clients includes Abbott, Roche, Siemens, others].ProjectProject ScopeDeliverables & StatusSite Validation ProgramEstablish the Validation Engineering Group. Site Validation SME and direct interaction with regulators. Validation issues resolution and validation documentation. Development, planning, approval, and execution of project plans. Lead meetings for project status, deviations, issues and corrective actions.Manufacturing operations validation remediation initiatives, resolution of complaints, defects, non-conformance issues.Validation, Qualifications, Process documentations in-place for manufacturing processes operations in validated state.CompleteValidation SupportValidation Master Plans, URS, FRS, FAT, SAT, Commissioning, Qualification, Validation for New High Volume Filling Lines.Change Control Management (e.g.: Impact and Risk Assessments, FMEA and reports. Direction to Engineers and Consultants (VMP, URS, FRS, FAT, SAT, Commissioning, Qualification, Validation) and Training.CompleteNew Container (Rigid containers alternative - deflated format for diagnostics reagents). Bladder Inflation & Carton Assembly Equipment, Controlled Manufacturing & Universal Inflation.Engineering support for project strategy and deliverables to qualify alternative supplier(s) for current Cubitainers.Process Validation of Bladder Inflation & Carton Assembly Equipment, Controlled Manufacturing & Universal Inflation.CompletePeriodic Mapping of conditions of Critical Storage Systems.Maintenance of validated state for temperature, humidity, etc., and ensure products and constituents are safe, efficacious, and remain within its approved shelf life @ various storage conditions.Complete.IMA Lyophilizers, Autoclaves and Formulation Tanks, Glucose Tolerance Test Beverage (GTTB) Manufacturing New CIP SystemQualification oversight, process and cleaning validations.GTTB Product Manufacturing improvements and upgrades of process flow and utilities circuits, equipment systems, manufacturing process re-validation.New CIP System URS & FRS, Vendor selection.Complete..New High Volume Fill Lines (Abbott, Roche, Siemens, Cardinal Health, etc.).Validation Engineering support for URS, FRS, GMP requirements, and relevant documentation.Complete.Principal Engineer Millipore Sigma St Louis, MO Biotechnology Jan 2018 Dec 2018 (Merck KGaA Darmstad Germany Susidiary)Anitbody Drug Conjugates, Bioconjugation, API Plant & Animal Sourced. Clients includes GSK, Takeda Pharmaceuticals, Medimmue, Asana, Astellas, Pfizer. Therapeutic protein extraction and purification, bio-conjugation, excipients and adjuvants manufacturing.ProjectProject ScopeDeliverables & StatusADC (Anti-body Drug Conjugates), Bioconjugation, API Plant & Animal Sourced engineering support.Plant and animal-based therapeutic protein extraction and purification, bio-conjugation, excipients and adjuvants manufacturing.CompleteEarly and Late phase cGMP API and Commercial Products ManufacturingCompletion of validation activities for Manufacturing Facilities, Process Equipment, Process Validation (or PPQ) for New Manufacturing Processes. Oversight of Cleaning Validation Projects [Dose or Toxicity-Based Residual Limits and EMAs Heath-Based Cleaning Limits (PED)], Cleaning Process Development, DEHT, CEHT.CompleteCross-functional interaction with Stakeholders and Technology TransferCollaboration with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Materials Management, Engineering, Maintenance and Customers Project Management, Technical and Quality Groups for SOW for new products/projects and process validation (PPQ) for commercial scale.GSK Product Manufacturing Runs - CompleteAssessment & Periodic Reviews of GMP Systems and EquipmentConfirmation of the validated state.Complete.Data Integrity Issues and New Disinfectant QualificationSupport the Identification and implementation of Data Integrity Issues and execution of required remediation and/or action plans (CAPA). and/or action plans (CAPA). Review and approve project plans.CompleteNew DisinfectantReview and approve project plans for the qualification of new Disinfectant.CompleteCritical System Lifecycle DocumentationValidation Master Plans, URS, FRS, Validation Protocols (IQ/OQ/PQ), Traceability Matrix, Validation Reports, SOPs, Change Control Documentation, Risk & Calibration Risk Assessments.CompletePrincipal Engineering Consultant PSE LLC San Diego, CA January 2012 December 2017ProjectProject ScopeDeliverables & Status1. Pfizer McPherson, KSPharmaceuticalsFDA Warning Letter.Resolve issues contained in the FDA Warning letter for violations:Investigation of unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications per 21 CFR 211.192, (21 CFR 211.110(b),21 CFR 211.113(b), (21 CFR 211.160(b).Complete2. Innovize St. Paul, MNDrug Device Combination ProductsHemostatic Dressing product (Class III Medical Device Manufacturing.Engineering program management for the companys client Hemostatic Dressing Product (Class III Medical Device) to commercial scale manufacturing.SurgiClot Dextran Mat Crimp Study, Operational Qualification of Tray Sealing of SurgiClot Dressings, SurgiClot Hemostatic Dressing Training Pilot Production Protocol, SurgiClot Hemostatic Dressing Manufacturing Process Validation Plan.Complete3. Takeda Pharmaceuticals Brooklyn Park, MN - Manufacturing Facility Upgrade.Commissioning, Equipment, Facilities, Utilities, Cleaning Validation, Sterilization and Process Validation Programs.Complete4. CECON Group Wilmington DE Pharmaceuticals, Biotech, Drug Device Combination ProductsDesign a pharmaceutical manufacturing facility (Injectables). plans and specifications per cGMP requirements. Oversight of MEPs for utilities requirements of the manufacturing facility.Complete5. Medtronic Fridely, MN Drug Device Combination ProductsImplantable Infusion Pump Systems, deliver medication for metastatic cancer, chronic pain and severe spasticity.Consent Decree Remediation per Quality System Regulation Medical Devices CFR) Title 21, Volume 8, Section 820.70 Production and Process Controls and ISO10993-10. Consideration during manufacture and assembly of medical devices, chemical components may be used as processing aids, e.g. lubricants or mold-release aid.Develop resolution plans for submittal to the FDA encompassing Cleaning Validation deficiencies per FDA audits (Medtronic CAPA 222182). Priority action items to meet the provisions of the Consent Decree.- Assessment of cleaning validation gaps for remediation and re-validation, Site Validation Master Plan.- Cleaning Validation Master Plan (CVMP) to comply with the observations included in the Consent Decree- Processes in place to assure the design, manufacture and distribution of a device allows for its safe use.- Presentation to management and the ranks showing the differences of cleaning validation approaches for Pharmaceutical, Biotech vs. Medical Devices.Complete6. Intarcia Therapeutics, Hayward, CA Treatment For Type 2 Diabetes and Obesity - A subcutaneous delivery system, comprised of a small, matchstick-sized osmotic pump that is placed sub-dermally (just beneath the skin) to deliver a slow and consistent flow of medication.Engineering support.- Validation Packages for WFI System Upgrade, Clean Dry Compressed Air and Nitrogen Systems.- User Requirements Specifications (URS, Risk Analysis (FMECA), Engineering Change Documentation, Validation Matrix and IQ, OQ, PQ Protocols including execution and Validation Final Reports.- Good Engineering Practices (GEP) and Validation Gap Assessments for Processes, Equipment (Current & New), WFI, Clean Steam, Nitrogen, Clean Rooms & HVAC, CIP & SIP Systems; and Indirect Impact Utilities (Chilled Water System, RO/DI, Plant Steam, Boiler, Cooling Tower), review Commissioning Documents.- EWP for qualification and validation of systems, equipment, processes and utilities, assistance to PM Program for Regulated Assets and Major Utilities.CompleteProjectProject ScopeDeliverables & Status5. Genentech Vacaville, CAProteins From Mammalian Cells (Avastin, Cytovene, Rituxan) - Remediation per regulatory audit observations.- Optimize and improve cleaning, sanitization and disinfection processes. Minimize the impact of erosion on facilities, equipment and utilities due to sanitization and disinfection processes.CompleteProjectProject ScopeDeliverables & Status6. Par Pharmaceuticals Rochester, MI Branded And Generic Aseptic Injectable Pharmaceuticals (Brevital Sodium, Coly-Mycin, Ketalar, Triostat)Cleaning Validation & Cleaning Validation Master Plan development and implementation.Assessment of products to be covered in the plan, develop Cleaning Matrix, Process Standardization.Cleaning Calculation Methods for Fill Equipment, Process Vessels, Wash Equipment and Lyophilizers.CompleteProjectProject ScopeDeliverables & Status7. Abbott Laboratories San Diego, CAIn-Vitro Diagnostics Products (Cardiac Markers, Point Of Care Test)FDA Warning Letter, Internal CAPA covering Gap Assessment, URS & Validation Master Plan, Equipment and Process Parameters.Remediation tasks per FDA Warning Letter and Internal CAPA) covering Gap Assessment, URS & Validation Master Plan, Equipment and Process Parameters (Centrifuges, Chromatography Columns, Aseptic Filtration, Fume Hoods).Engineering & Optimization Studies, IQ/OQ/PQ/PV execution and final reports for Equipment, Facilities, Clean Utilities, Process & Cleaning Validation, Regulated Assets inclusion to the PM Program (Maximo) for Final Product and Reagent Anti-Body Coating Process.CompleteProjectProject ScopeDeliverables & Status8. Teva Pharmaceuticals Greensboro, NC Pharmaceuticals OTC Products (Pepto Bismol, Nyquil, DayQuil, ZQuil, Prilosec, Vicks)Site cGMP Upgrades and Plant Capacity Expansion.Upgrades to support new and current Products consisting of: Chilled Water System, Purified Water Supply (USP), CIP Systems, Compressed Air System, Process and Reaction Tanks. Oversight of Process & Cleaning Validation for the Central Dispensing and Closed Manufacturing, New Controlled Spaces & Equipment in Manufacturing.CompleteSenior Principal Engineer Abbott Laboratories Temecula CA Drug Device Combination Feb 2005 May 2012 (Retired)XIENCE V Everolimus Drug Eluting Coronary Stent System, for the treatment of Coronary Artery Disease. Other products: Bare Metal Stents, Balloon Catheters, Guide Wires and Blood Vessel Closure Devices.Completed projects for Engineering, Manufacturing, Abbott Vascular Analytical Labs, R&D and Quality/RC: Validation support for US, Puerto Rico, Ireland, Costa Rica. Project Team Leader for Steris Sterilizer validation for lab equipment and biohazard waste decontamination. Assumed responsibility to validate the equipment after unsuccessful Vendor qualification runs. Reviewed previous thermal map and profiles, determined the cause of failures was due to the plant steam supply deficiencies and quality which resulted in cold spots and equipment not meeting acceptance criteria. Projected Cost Savings: $300K/Yr.Integrated Commissioning & Qualification, DAT, FAT, SAT, IOPQ of Facilities, Process Equipment, Analytical Lab and R&D Equipment, Clean Room HVAC, Process, Clean Compressed Gases, BMS, URS,FRS write up, Change Management.Validation Master Plan (VMP); IOPQ, PV Executions; Re-Validation Projects Gap Analysis and CAPA Implementation.Established Validation Master Plan (VMP) for the site wide conversion, qualification, validation of the Low, Medium, High Pressure Compressed Air Supply to Clean Compressed Air Oil Free System (IOPQ completed).Created Clean Compressed Gasses (Ar, CDA, N2, O2, He) Distribution Map (includes PFD, P&ID) for all Abbott sites (FDA audit issue, CAPA resolution). Identified the compressed gasses sampling points for Routine Analytical and Microbial Testing (meets guidelines for Moisture, Oil, THC, Purity, Non-Viable & Viable Particulates).Created Cleaning Validation Work Packages covering Deliverables, Completion Criteria, Resources and Costs required to demonstrate that the cleaning process removes residue to a pre-determined level.Project Leader for Cleaning Validation of Glassware Washer Equipment used companywide (Domestic/Off-Shore), CAPA issue per FDA and Corporate audits. Trained as a Subject Matter Expert (SME) to represent Abbott on external audits by US FDA, CDRH, BSI, OSHA, EPA, MEDCERT, and Japanese Regulatory Agency.Cleaning Validation Project and disinfectant qualification. Developed Validation Protocol and Final Report formats, used as a template to validate Drug Eluting Stent (DES) ISO Class 7 Manufacturing Clean Rooms. Wrote the Facilities Qualification Guidelines and Major Components List SOP. Lead Validation Engineer for the qualification and validation of a new Extrusions Plastic Continuous Melt Flow Characterization Equipment for incoming raw materials test. Five (5) headcount reduced.Senior Principal Engineer Alliance Medical Product Irvine, CA Pharmaceuticals Feb 2004 Feb 2005Contract Manufacturer, Specialty: Difficult to manufacture Pharmaceutical Formulations i.e. Solutions, Suspensions, Emulsions, Sterile Ointments, Gels and Medical Devices. Clients: Bausch & Lomb, ISTA Pharmaceuticals, Pall Medical, NovartisManaged engineering and maintenance of Aseptic Fill Manufacturing Facilities, oversight of new construction and validation assistance for Clients New Aseptic Filling Suites, FAT, SAT, Commissioning, Start-Up and IOPQ, of Automated Filler/ Stopper/Capper, Labeler, Inspection Systems (Vision Systems), Packaging, Autoclaves, De-Pyrogenation Ovens, Sterilizers, Vial Washers, Utility Systems (WFI, R.O. Water, Plant & Clean Steam, Compressed Air/Gasses, City Water).Project Team Member for Process Validation [TSB (Media) & Product Runs] and Certification of a New Automated Aseptic Fill Facility (ISO Class 5/Class 100, increasing capacity by fivefold (5X), Process Development Manager for Solid Dosage Manufacturing. Engineered, commissioned and qualified a non-functional WFI System Project including the passivation of the HWFI Distribution System reducing WFI cost by 60%.City Water Supply Booster Pump installation reducing interruptions during generation of R.O. Water, Clean Steam and WFI (low water pressure for Condenser cooling). Converted Purified N2 Supply to Ultra-Clean Compressed Air Supply (40 0F Dew Point, Meets ISO 8573, Air Quality Classes) reducing material cost by 85%.Designed, qualified a CWFI Supply to Formulation Room (for New Clients) and Vacuum Equipment for weigh checks of in-process samples during Aseptic Filling (Meets Hazardous Environments Requirements, Class 1, Div. II), designed, installed and qualified Electric Torque Cappers, replacing manual capping of aseptically filled pharmaceutical vials to minimize problems associated to Carpal Tunnel Syndrome. Designed and installed In-Process Sampling Equipment used during Aseptic Fill Operations for regular products and special product runs (hazardous contents).Constructed and certified a New Aseptic Fill Facility for New Clients and Products. Resolved customer complaints on staining of sterilized products (CAPA) by installing Auto-Blow down and Heater upgrades for the Steam Boiler, revision of Clean Steam piping (Productivity), installation of a New Clean Steam Sampling (for Cleaning Validation & Safety).Cleaning Validation initiatives for product contact equipment. Prior to the equipment use for another product manufacturing, cleaning is instituted to remove and/or reduce the level of API.Designed and installed In-Process Sampling Equipment used during Aseptic Fill Operations for regular products and special product runs (hazardous contents). Constructed and certified a New Aseptic Fill Facility for New Clients and Products. Resolved customer complaints on staining of sterilized products (CAPA) by installing Auto-Blow down and Heater upgrades for the Steam Boiler, revision of Clean Steam piping (Productivity), New Clean Steam Sampling (for Cleaning Validation & Safety).Engineering Consultant Naderi Engineering Inc. Danville, CA Biotechnology Oct 2002 Feb 2004Biogen Idec & Genentech - Oceanside CA, Vical - San Diego CAMonoclonal Anti-Body Based Products; Non-Hodgkins Lymphoma (NHL Zevalin); Autoimmune Diseases (Rituxan Rheumatoid Arthritis). DNA Vaccines i.e. Cytomegalovirus (CMV), Anthrax, Ebola, HIV, SARS, InjectablesEngineering assistance for P&ID, installation, commissioning, qualification of Biopharmaceutical Facilities, Equipment, Utilities, Process & Cleaning Validation.Technical support for Bio-Reactors, Buffer Preparation Tanks, Purification Pool Tanks, Chromatography Skids, Tempered Water Skids, UF/DF Skids, CIP & SIP Systems, Westfalia Centifuge, Lyophilizers, Clean Compressed Gases, DIW & WFI, Plant & Clean Steam and Cell Culture Production Clean Rooms for Upstream Process: Seeding Working Cell Bank, Culture Vessels to Production Bio-Reactor, Harvest (Depth and Membrane Filtration). Downstream Purification (Low pH Viral Inactivation; Protein, Cation & Anion Chromatography; Depth and Ultra/Dia-Filtration, Lyophilization.Completed design, fabrication of Equipment, Utility Systems, P&ID, IOPQ/PV Protocols for Validated Systems, HVAC and BMS, Equipment FAT/SAT, qualification & validation of Processes and Cleaning Validation.Cost Savings Contributions:Assumed responsibilities for the Pharmaceutical Clients Plant and Facility Engineering Projects (Incumbent Engineer Illness). Met Operational Qualification schedule for WFI, RO/DI, Clean Steam, Clean Rooms and BMS.Performed Mass/Heat Balance for Plant Steam, HVAC/ HHW and City Water (Soft Water, RO/DI, Boilers, Domestic, Cooling Tower, Chilled Water). Cost Avoidance: +$500K for New Equipment.Installed, qualified a back up Compressed Air Supply |
