BENJAMIN M. ZARZA

***** ********* *** *** *****, CA 92129

Tel. No.: 858-***-**** e-mail: acqcb9@r.postjobfree.com (primary) acqcb9@r.postjobfree.com (alt)

Extensive engineering and validation experience within FDA and cGMP regulated environments (Domestic & Off-Shore). Self-starter, proactive and hands-on engineering for sterile and aseptic processing of Pharmaceuticals (Injectables, Prescription, OTC, Biologics, Generics), Drug-Device Combination (Class III, Implantable). Technical assistance for Remediation Projects (FDA Warning Letters & 483’s, Internal CAPA), Product Development & Lifecycle, Clinical Products (PMA & FDA 510K Submittals) thru commercialization.

PROFESSIONAL EXPERIENCE and COMPETENCIES

+ Overseen Capital Engineering Projects Design & Design Improvements, Construction, DAT, SAT, FAT, Integrated Commissioning & IQ, Qualification of Equipment, Utilities (Clean, GMP & Non-GMP), Systems, Manufacturing Facilities [Clean Rooms ISO Class 1, 4, 5, 6, 7; Aseptic & Sterile Filling (includes Form/Fill/Seal Systems for Large Volume Parenterals & Medical Devices)], Hazardous Environments, Process Validation and Cleaning Validation.

+ Engineered Critical Systems (WFI, RODI, USP Purified Water, Clean Steam, Clean Compressed Gasses), Equipment, Piping and Process Systems meeting cGMP, GDP, GEP, GXP, 21 CFR 820 Parts 11, 210/211, 600/601/610 (Quality System Regulation), ISO 13485 (Medical Devices Quality Requirements), ICH Q7 Requirements.

+ Established Process Flow Diagram (PFD), Piping & Instrumentation Diagram (P&ID), URS, Equipment Specifications. Knowledge of Unit Operations, Mass Balances, Heat Transfers, Lyophilization, Fluid Bed Drying, Centrifugation, Filtration, CIP & SIP, Sterilization (Steam, ETO, Electron Beam, Gamma Radiation, VHP, Depyrogenation).

+ Managed A/E Contractors, Project, Process, Plant and Facilities Engineering. Identified, troubleshoot problems and provided cost effective solutions to maintain and increase productivity. Tactical and strategic planning leadership for Process Characterization and Improvements, Process Scale Up, Technology Transfers, Automation/Mechanization.

+ Led Validation, Engineering, Compliance and Remediation Tasks encompassing initiation, design, construction, commissioning and re-commissioning, plant start-up, validation and project closure for biopharmaceutical equipment, processes, manufacturing facilities and utilities (Clean & Plant) meeting FDA and cGMP requirements.

Defined Validation Strategies (based on User Requirements Specifications, Gap & Risk Assessments, Audits, Impact & Failure Mode Analyses). Developed and maintained Validation Master Plans, systems validation documentation, generated and executed test protocols and summarized validation results in final reports.

Provided engineering expertise and responsible throughout the system development life cycle (SDLC), validation of new systems and qualification of changes for existing systems via Engineering Change Control Process to assure that critical systems and regulated assets remain in a validated state.

Planned and coordinated Process Validation Projects by working with various departments and stakeholders to assign responsibility for protocol generation, execution, and review including interfaced with Engineering, Facilities, Quality, Regulatory, and Manufacturing Personnel. Provided guidance, leadership and oversight for engineers to write and execute qualification and validation protocols, reporting to other managers.

+ Implemented Cleaning Validation Projects to ensure that the residue level (API, Chemical, Viable and Non-Viable Particulates) from various agents including contaminants produced during the manufacturing process which require later removal, meets acceptance criteria. Assessed processes that may produce potential contaminants.

Led Cleaning Methods Cycle Development (Measurement of Cleanliness, Residuals Identification for removal, Optimum Cleaning Method, How clean is clean?) to clean the surfaces to ensure end-user safety and the product will function as intended. Assisted in identifying chemicals coming into contact with the product and calculated product contact surface areas (manufacturing and cleaning), including components supplied by outside sources that could potentially remain during the manufacturing process.

+ Generated SOPs, Qualification and Validation Protocols for Processes, Equipment, Facilities, Water Systems (RO/DI, WFI), Clean Steam, Clean Compressed Gasses, Clean Room Systems & HVAC, CIP & SIP Systems. Established validation documentation, which include validation plans, audit plans, requirement specifications, test plans, IQ, OQ and PQ protocols, test cases/scripts, traceability matrices and validation reports.

+ Completed qualification, validation, compliance and regulatory projects for manufacturing facilities, equipment, systems and utilities for manufacturing including Water for Injection (WFI), Compressed Gasses, City Water, Hot & Chilled Water, Clean Steam & Plant Steam. Ensured efficient operation within demand required ranges.

PRINCIPAL PARTNER & SENIOR CONSULTANT PSE LLC San Diego, CA January 2012 – Current

CURRENT & COMPLETED PROJECTS

Engineering Consultant CECON Group Wilmington, DE January 2015 – Current

Cosmetic Surgery Products – California

Engineering oversight for Process Scale Up and GMP Facility construction. Stem-Cell enhanced fat injection for cosmetic enhancement. The fat is harvested through liposuction for stem cell extraction. The stem cells are further processed for the final injection. Conceptual designs and specifications are being developed.

Oral Dosage and Extended Release Pharmaceutical Products - China

Provide engineering technical assistance to construct a facility to manufacture oral dosage and extended released products in China to comply with US FDA requirements. Reviews of designs, specifications for equipment, systems, facilities, utilities and site including preliminary process flow diagram.

YPEX Technology Resources Client: INTARCIA Therapeutics Hayward, CA September 2014 – February 2015

Developed and completed Validation Packages for the WFI System Upgrade, Clean Dry Compressed Air and Nitrogen Systems. Tasks involves generating User Requirements Specifications (URS, performing Risk Analysis (FMECA), Engineering Change Documentation, establishing Validation Matrix and authoring IQ, OQ, PQ Protocols including oversight of execution and generation of Validation Final Reports.

Performed Good Engineering Practices (GEP) and Validation Gap Assessments for Regulated and High Value Assets encompassing Processes, Systems, Process Equipment (Current & New), Direct (WFI, Clean Steam, Nitrogen, Clean Rooms & HVAC, CIP & SIP Systems) and Indirect Impact Utility Systems (Chilled Water System, RO/DI, Plant Steam, Boiler, Cooling Tower) including reviews of Commissioning & GMP Systems Documentation.

Developed Engineering Work Packages for qualification and validation of systems, equipment, processes and utilities based on gap assessments. Assistance to establish the PM Program for Regulated Assets and Major Utilities.

WGA Consulting Client: GENENTECH Vacaville, CA June 2014 – September 2014

Implemented projects based on internal and external audit observations to optimize and improve cleaning, sanitzation and disinfection processes while minimizing the impact of erosion on facilities, equipment and utilities. Responsibilities encompasses but not limited to:

oReview and assessment of site documentation against industry practices.

oConduct Cleaning Methods observations (including thermal assessments), assess practices versus SOPs, Policies and Industry Practices for cleaning.

oEstablish interview sessions with Stakeholders and generated Final Report on findings.

oRemediation and harmonization of cleaning methods.

VTS Consultants/LVS Inc Client: PAR PHARMACEUTICALS Rochester, Michigan June 2013 – May 2014

Cleaning Validation Master Plan development and implementation, assessed products to be covered in the plan, developed Cleaning Matrix, Process Standardization, and Cleaning Calculation Methods. Supported the upgrade and validation of CIP Systems for Process Tanks and Aseptic Filling Equipment to reduce turn-over and cycle times, water consumption and sanitization frequency. Tasks include optimization of Data Collection, Temperature Control, CIP Processes and incorporation of other technologies, i.e.: On-Line TOC Analyzer, Ozone Disinfection, Water Clarity Monitors, Clear Trace Water ATP (real time/complements Bioburden Test) and Cleaner-Sanitizer Chemical.

Validant Inc. Client: ALERE, INC San Diego, CA January 2013 – May 2013

Implemented remediation tasks (FDA Warning Letter) for an In-Vitro Diagnostics Products Manufacturer (Cardiac Markers, Point Of Care Test), San Diego, CA covering Gap Assessment, URS & Validation Master Plan, Equipment and Process Parameters Engineering & Optimization Studies, IQ/OQ/PQ/PV Protocol generation & execution, Final Reports for Equipment, Facilities, Clean Utilities, Process & Cleaning Validation, inclusion of Regulated Assets to the Preventive Maintenance Program (Maximo) to support Final Product and Reagent Anti-Body Coating Process.

Randstad Engineering Client: TEVA PHARMACEUTICALS Greensboro, North Carolina June 2012 – December 2012

OTC Products (Pepto Bismol, Nyquil, DayQuil, ZQuil, Prilosec, Vicks)

Technical assistance for the site cGMP upgrades and plant capacity expansion initiatives for new products and products from other sites, and upgrades of Chilled Water System, Purified Water Supply (USP), CIP Systems, Compressed Air System, Process and Reaction Tanks. Lead Engineer for Process & Cleaning Validation for the Central Dispensing and Closed Manufacturing, New Controlled Spaces & Equipment in Manufacturing.

Implemented projects that improved dispensing of raw materials charged into Process Reaction Tanks and Milling Equipment. Raw Material contents are: API, Combustible Dusts, Dyes, Flavors, Flammable Liquids (hazardous classification per NEC, NFPA). Weighing and Dispensing Operations performed in the production areas are relocated to controlled and contained areas. Developed alternatives for the opening and emptying ingredients from bags or stainless buckets in production and means of delivering dispensed materials to the production and handling.

Assisted New Wash Machines installation and updates for Clean In Place System for the added piping and valves.

Developed the Master Raw Material Matrix, Raw Material Containers Matrix Spreadsheets (current & new), and Material Process Flow.

SENIOR ENGINEER ABBOTT LABORATORIES Validation Engineering Group Temecula, CA February 2005 – May 2012

Drug-Device Combination Products: XIENCE V Everolimus Drug Eluting Coronary Stent System, for the treatment of Coronary Artery Disease. Other products includes Bare Metal Stents, Balloon Catheters, Guide Wires and Blood Vessel Closure Devices. Implemented projects for Engineering, Manufacturing, Abbott Vascular Analytical Labs, R&D and Quality/RC covering: Validation support for US, Puerto Rico, Ireland, Costa Rica.

Completed projects for Engineering, Manufacturing, Abbott Vascular Analytical Labs, R&D and Quality/RC covering: 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 difficiences 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 the 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 the 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 company wide (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, Japanese Regulatory Agency. Member in 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 Extrusion’s Plastic Continuous Melt Flow Characterization Equipment for incoming raw materials test. Five (5) headcount reduced.

SENIOR ENGINEER ALLIANCE MEDICAL PRODUCTS Irvine, CA February 2004 – February 2005

Contract 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, Novartis

Managed engineering and maintenance of Aseptic Fill Manufacturing Facilities, oversight of new construction and validation assistance for Client’s New Aseptic Filling Suites

Completed installation, FAT, SAT, Commissioning, Start-Up and IOPQ, of Automated Filler/ Stopper/Capper, Labeler, Inspection Systems (Vision Systems), Packaging, Autoclaves, Depyrogenation Ovens, Sterilizers, Vial Washers, Utility Systems (WFI, R.O. Water, Plant & Clean Steam, Compressed Air/Gasses, City Water).

Responsible for engineering support and 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 five fold (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%.

Installed City Water Supply Booster Pump that reduced 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 an 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).

Provided assistance to Cleaning Validation iniatives for product contact equipment. Prior to the equipment use for another product manufacturing, cleaning is instituted per established SOP to remove and/or reduce the level of API.

Designed and installed an 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).

Provided assistance to Cleaning Validation iniatives for product contact equipment. Prior to the equipment use for another product manufacturing, cleaning is instituted per established SOP to remove and/or reduce the level of API.

ENGINERING CONSULTANT NADERI ENGINEERING INC Danville, CA July 2002 – February 2004

Clients: Biogen Idec & Genentech (Oceanside, CA), Vical (San Diego, CA - Engineering assistance for the design (P&ID), installation, commissioning, qualification of Biopharmaceutical Facilities, Equipment, Utility Systems and Process & Cleaning Validation to support: Monoclonal Anti-Body Based Products; Non-Hodgkins Lymphoma (NHL Zevalin); Autoimmune Diseases (Rituxan Rheumatoid Arthritis). DNA Vaccines i.e. Cytomegalovirus (CMV), Anthrax, Ebola, HIV, SARS.

Provided engineering and maintenance support for Equipment (Bio-Reactors, Buffer Preparation Tanks, Purification Pool Tanks, Chromatography Skids, Tempered Water Skids, UF/DF Skids, CIP & SIP Systems, Westfalia Centifuge, Lyophilizers), Utility Systems (Clean Compressed Gases, DIW & WFI, Plant & Clean Steam) and Cell Culture Production Clean Rooms for Upstream Process: Seeding (w/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, Lyophilzation.

Completed tasks for the 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 Client’s 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 System (Medical Grade) eliminating plant shutdowns/GMP Runs disruptions by air pressure fluctuations and system maintenance. Savings: +$200K/Aborted Product Lots.

- Eliminated plant steam bleed-through from WFI Still & Clean Steam Equipment. Reviewed system design, audited steam traps, replaced improperly sized/non-functional units, Energy Savings: +$100K/Yr.

ENGINEERING CONSULTANT CECON GROUP Wilmington, DE April – July 2002

Qualified and supported the validation of a Heart Valve Manufacturing Process (New Contour Ring) from Porcine Tissue, (Class III Medical Device, Implantable) for Medtronic Inc., CSG reducing scrap by $65K/Month.

DIRECTOR of ENGINEERING WILSHIRE TECHNOLOGIES Carlsbad, CA & Tijuana, Mexico April 1994 – April 2002

Products for Nanotechnology & Microelectronics, Food, Medical Devices, Biotech and Safety. Major Customers includes Guidant, Toshiba, Motorola, Intel, Sony, Panasonic.

Managed engineering functions and controls for Manufacturing Facilities; Equipment, Plant & Facility Engineering. Sustained plant operations and New Products; Cost Savings, Safety, Pollution Control; PM Program (CMMS based).

Project Manager for an Automated Polyurethane Rubber (Dupont Lycra) Glove Manufacturing Plant (Capitalization $7.5 MM, Solvent Based Process) with VARA DMAC Solvent Recovery System in Tijuana, Mexico Constructed and qualified ISO Class 1, 6 (1000) & 7 (10,000) Clean Rooms for downstream and packaging operations.

Developed processes to remove Non-Volatile Residues (NVR, Patent Pending). Met ultra-clean requirements for Electronics, Photolithography and Medical Devices. Built an NVR Cleaning Facility (Class 100 Clean Room, Hazardous Environment Class I, Div. II with IPA Recovery). NVR affects electronic devices accuracy, cure of Medical Device components and cell activity of Biotech Products.

PRINCIPAL MANUFACTURING ENGINEER BAXTER INTERNATIONAL Irvine, CA March 1990 – April 1994

Worked with Manufacturing and R&D in solving production problems, technology transfer for Pulmonary Artery Catheters, Blood Pressure, Hemodynamic Monitoring, Venous Arterial Management, Introducer Catheters to Off-Shore. Member in New Product Design (Concurrent Engineering), MRB, CCB, CIP, QIT.

Influenced New Product Design for manufacturability and ease of assembly (DFM) via Concurrent Engineering (IPD) contributing to 25% of the Division’s profits.

ENGINEERING MANAGER KENDALL HEALTHCARE San Diego, CA/Tijuana, Mexico July 1987 – April 1990

A Division of Tyco International (Medical Devices – Urology, Fluid Management and Respiratory & Surgical Products)

Overseen and managed Capital Project implementation, assumed responsibilities for Project, Plant Engineering, Maintenance, Plant Upgrades, Cost Improvement, support of JIT, Cellular Production re-alignment for products from Manufacturing Plants in the U.S. and consolidated in Mexico.

Constructed new Manufacturing Facilities for Respiratory Care Products and Urological Catheters and a Central Corrugate Transfer Area to process products from the Focus Factory.

Constructed, qualified new Manufacturing Facilities (Focus Factory), Plastic Injection Molding & Extrusion Processes Validation for Respiratory Care Products and Urological Catheters and a Central Corrugate Transfer Area. Resolved the inadequate supply of chilled water to Molding & Extrusion. Determined that San Diego Airport temperature was used as a design basis instead of prevailing conditions in Tijuana, Mexico. Cost Savings: $300K/Yr.

PRINCIPAL PROJECT ENGINEER IMED CORPORATION San Diego, CA January 1984 – July 1987

A Warner Lambert Subsidiary- Medical Devices - Infusion Management System (IV Drug Delivery Systems, Infusion Devices, Patient Vital-Signs Monitoring Instruments & Disposables)

Supported Disposable Products manufacturing. Installed Flexible Manufacturing System, Bar Code System, CIMS (Injection Molding). Overseen Automation/Mechanization Projects. Designed a Silicone (MDX) Coating - Drying Equipment (Explosion Proof, Hazardous Environment Class I, Div. II).

Developed the RODI System Sanitization SOP, assisted technology transfer to Off-Shore and Clean Room Certification.

Implemented Automation and Mechanization Projects eliminating manual labor. Cost Savings: $500K per annum.

PRINCIPAL PROCESS ENGINEER ABBOTT LABORATORIES HPD Los Angeles, CA April 1975 – January 1984

Pharmaceuticals (Injectables – Therapeutic Drugs from Human Blood Plasma Fractionation i.e. Anti-Hemophilic Factor, Prothrombin Complex, Albumin, PPF, Anti- Hepatitis (HBIG), Anti-Tetanus, Anti-Rh Factor

Implemented Capital Projects, Capital Funding Requests, construction and installation. Projects completed includes New Manufacturing Facilities [Fractionation, PTC, Acetone Drying (ISO Class 10 & 100 Clean Rooms)]; Tank Farm; Equipment Systems (Centrifuges, TFE, Sterilizers, Lyophilizers, WFI Still, Clean Steam, CIP, SIP, Chilled Water, Electro-Dialyzers), Closed-Loop WFI Supply System, AHF Cryo-Harvest Rooms (New Westfalia Centrifuges, Plasma Pool). Completed projects for Sterile Filtration and Aseptic Fill Facilities (Capitalization: $18 MM), Production Facilities for AHF–Factor VIII, PTC–Factor IX, HBIG, Anti-Tetanus, Anti-Rh, PPF, Albumin. (Increased market share by $100MM).

Formerly with R & D Technical Operations, implemented tasks for process optimization & validation, cleaning validation. Qualified Equipment in the Pilot Plant prior to use in manufacturing.

EDUCATION, CONTINUING EDUCATION AND TRAINING

Bachelor of Science in Chemical Engineering Far Eastern University Manila, Philippines

Project Management (Franklin Covey), Process Quality Control and SPC, Validation of Process Control Systems

Process & Software Validation, Lean Manufacturing and Six Sigma/DMAIC,

Clinical Applications of Biomedical Engineering and Cardiovascular Physiology – University of California Irvine

CGMP, ISO Refresher Courses, 21 CFR Part 11, 210, 211, 820, Seminars for Primavera and Trachwise

Analytical Instrument Qualification & System Validation, Steam Sterilizer Validation Per ISO 17665-1

ISPE Training, Risk-based Approach to Commissioning and Qualification (GAMP4/5) incl. Baseline Guide Vol. 5

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