Chemical Engineer Specializing In Pharmaceutical Capital Projects and Facilities With cGMP, FDA and ISO Requirements

Technical Consultant #1207


Expertise

  • Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.
  • Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.
  • Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.
  • Strategic planning leadership for process improvements, process/product scale up, technology transfers, clean rooms (ISO 14644, including environmentally controlled/hazardous environments); automation/mechanization; process validation [IQ, OQ, PQ, PV, 21 CFR part 11].
  • Processes for: Pharmaceutical, aseptic, sterile, ultra-clean, closed system (fermentation, purification, cell culture), solid dosage manufacturing (tablets, powder filling), human blood plasma fractionation; medical devices; utility systems for: WFI, clean steam, R.O./D.I. water (USP), plant steam, ultra-clean compressed air/gasses, hot/chilled water supply.
  • Knowledge and capabilities: PFD, P&ID, design, start-up, commissioning, equipment specification and SOP write up; unit operations, mass balances, heat transfers, lyophilization, fluid bed drying, centrifugation, filtration, CIP/SIP; FMECA, concurrent engineering, lean manufacturing and six sigma.
  • Predictive and preventive maintenance programs (CMMS based); Building Management Systems (DDC), HVAC, Heat and Waste Water Reclamation and Neutralization.
  • Resources and schedule management.
  • Accountability of capital projects; new processes scale up and process equipment modifications.

Accomplishments

  • Biopharmaceutical facilities and equipment systems design, commissioning, qualification and validation of biopharmaceutical facilities and equipment systems for: Monoclonal anti-body based products for clinical trials and new product launches for NHL autoimmune diseases (Rituxan & Zevalin), and for DNA Vaccines (Infectious Diseases) i.e. Cytomegalovirus (CMV), Anthrax, Ebola, HIV, SARS.
  • Reviewed design, fabrication of equipment, utility systems, P & ID, IQ/OQ/PQ/PV Protocols for Validated Systems, HVAC and DDC (BMS). Participated in the FAT/SAT and qualification of critical systems.

Cost Savings Contributions

  • Responsibilities: Client's plant and facility engineering (Incumbent Engineer Illness).
  • Met operational qualification completion schedule for WFI, RO/DI, clean steam, clean rooms, BMS (DDC).
  • Performed mass and heat balance for plant steam, HVAC HHW and city water (soft water, RO/DI, boilers, domestic, cooling tower, chilled water). Realized a savings of over $500 thousand in new equipment.
  • Designed/installed a back-up compressed air supply system (medical grade) eliminating plant shutdowns/GMP runs disruptions by air pressure fluctuations and system maintenance.
  • Over $200 thousand in cost avoidance for aborted biopharmaceutical product lots.
  • Eliminated plant steam bleed-through from WFI still and clean steam equipment.
  • Reviewed system design, audited steam traps, replaced improperly sized/non-functional units, with and energy savings of over $100 thousand per year.
  • Served as a Senior Engineer and Technical Consultant for a pharmaceutical products outsource manufacturer - specialty: Hard to produce pharmaceuticals and medical devices, clients includes: Bausch & Lomb, ISTA Pharmaceuticals, Pall Medical, Senju, Novartis, Tyco, and ABS.
  • Responsible for engineering, management and maintenance of new manufacturing facilities, oversight of new construction and validation of new aseptic filling suites [ISO Class 5/Class 100 (FS 209E), IOQ, PQ, PV, certification]. Installation, FAT, SAT, commissioning, start-up and IQ/OQ/PQ of automated filler/ stopper and capper, labeler, inspection systems (Vision Systems), packaging, autoclaves, sterilizers, vial washers, utility systems (WFI, R.O. water, plant and clean steam, compressed air and gasses, city water).
  • Completed IOQ, PQ [TSB (media) and product runs] and certification of a new automated aseptic fill facility (ISO Class 5/Class 100 (Fed Std 209E), increasing manufacturing capacity by five fold.
  • Process Development Manager for solid dosage manufacturing: Developed and qualified a tabletting process for Pall Medical (API - sodium bicarbonate, no excipients and lubricants).
  • Completed the high cholesterol treatment products manufacturing scale up (API-colesevelam, sachet containers).
  • Enhanced sodium bicarbonate powder flowability during tabletting operations by developing a vacuum drying process and designing an automated powder feed system.
  • 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 F 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 during aseptic filling (meets hazardous environments requirements, Class 1, Div. II).
  • Qualified electric torque cappers (PQ & TSB), replacing manual capping of filled pharmaceutical vials to minimize problems associated to carpal tunnel syndrome.
  • Constructed and certified a new aseptic filling facility for new 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) and installation of a new clean steam sampling system (safety).
  • Completed projects for an $18 million sterile filtration/aseptic filling facility, pharmaceutical production facilities for AHF-Factor VIII, PTC-Factor IX, HBIG, Anti-Tetanus, Anti-Rh Factor, PPF, Albumin (therapeutic drugs, human blood plasma fractionation, injectables). Increased market share by $100 million.
  • Project Manager for an automated polyurethane rubber (Dupont Lycra) glove manufacturing plant (Capitalization $7.5 million, solvent based process) with VARA DMAC solvent recovery system in Tijuana, Mexico.
  • Developed processes to remove Non-Volatile Residues (NVR, patent pending). Meets ultra-clean operation requirements for electronics, photolithography and medical devices.
  • Installed an NVR cleaning facility (Class 1, Div. II, hazardous environments/IPA solvent recovery). NVR affects precision of electronic devices, cure of medical device components and cell activity for biotech products.
  • Qualified a heart valve manufacturing process (new contour ring) from porcine tissue, (Class III medical device, implantable) for Medtronic Inc., Cardiac Surgery Group reducing scrap by $65 thousand per month.
  • Influenced new product design for manufacturability and ease of assembly (DFM) via concurrent engineering (IPD) for critical care medicine products [pulmonary artery and introducer catheters (Class III medical device), blood pressure and hemodynamic monitoring, venous arterial management protection (adults and neonates, contributing to 25% of the division's profits.
  • Eliminated sterilized medical devices weak bond sites. Qualified the use of low emission solvents and adhesives. Savings of $500 thousand per year and was adapted by subsidiaries in Japan, Puerto Rico and Holland.
  • Resolved the inadequate supply of chilled water to molding and extrusion (urology, fluid management, respiratory and surgical products). Determined that San Diego Airport temperature was used as a design basis instead of prevailing conditions in Tijuana, Mexico. Cost avoidance of over $300 thousand per year.
  • Implemented automation and mechanization projects for Infusion management products eliminating manual labor resulting in cost savings of $500 thousand per year.

Experience

Undisclosed Company, Validation Engineering Services, 2006 - Present

  • Cardiac and cardiovascular devices: Coronary artery, endovascular and structural heart disease, vessel closure (Xience (DES), Absorb, MitraClip, Guidewires, Catheters).
  • Provide support to engineering, manufacturing, Abbott vascular test labs and global quality/RC.

Projects

  • Commissioning, IOPQ of medical device manufacturing facilities and equipment, HVAC, process, clean compressed gases (meets guidelines for moisture, oil, THC, purity, non-viable/viable particulates), automated systems, BMS, URS and FRS write up.
  • Change management system assessment, oversight of VMP development; IOPQ, PV executions; re-Validation projects gap analysis and CAPA (Rubric) Implementation.
  • Equipment and cleaning validation, installation/operational/performance qualification, DAT, FAT, and SAT.
  • Trained as a Subject Matter Expert (SME) to represent company during internal and external audits by US FDA, CDRH, CA DB, BSI, OSHA, EPA, MEDCERT, Japanese regulatory agencies.
  • Team member in cleaning validation project and implementation and disinfectant qualification.
  • Developed validation protocol and final report formats, used as a template to validate Drug Eluting Stent (DES).
  • Manufacturing suites (ISO Class 7 Clean Rooms) and new projects. Wrote the facilities qualification guidelines and Major Components List (MCL) SOP.
  • Established the Validation Master Plan (VMP) for the site wide conversion 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 for three Abbott sites (FDA audit issue resolution). Identified the compressed gasses sampling point locations for routine analytical and microbial testing.

Naderi Engineering Inc., Berkeley, CA ,Engineering, And Technical Consultant

  • Engineering, technical and validation services to the Biopharmaceutical and Medical Device Industries and as technical resource to engineering, manufacturing, facilities, maintenance and EHS.
  • Major clients includes Bayer, Genentech, Chiron, Biogen Idec, and Vical.

Wilshire Technologies, California and Mexico, 1994 - 2002

Director of Engineering

  • Products for Ultra-Clean (Electronics), safety and medical devices.
  • Major customers includes: Guidant, Toshiba, Motorola, Intel, Sony, and Panasonic.
  • Managed engineering functions and controls for manufacturing facilities, equipment, plant and facility engineering.
  • Sustained plant operations, new products through commercialization; cost savings, Safety and pollution control; preventive maintenance program (CMMS based).

Project Manager

  • As PM for the automated polyurethane rubber glove plant, $5.million capitalization (Dupont Lycra, DMAC/DMF solvent recovery), Class 1000/10,000 clean rooms for downstream and packaging operations, performed the following:
  • Implemented super critical carbon dioxide cleaning for polyurethane foam (used for clean room swabs, wipers, masks, rollers) as an alternative for CFC based and conventional cleaning processes.
  • 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.

Baxter International, Irvine, CA, Senior Principal Manufacturing Engineer, 1990 - 1994

Critical Care Medicine (Cardiovascular, Class III Medical Devices)

  • Worked with manufacturing and research and development 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, and QIT.

Kendall Healthcare, California and Mexico, Engineering Manager

  • For the Medical Devices - Urology and Fluid Management Division, oversaw and managed capital project implementation, assumed responsibilities for project, plant engineering, maintenance, plant upgrades, cost improvement, supported of JIT, cellular production re-alignment for products from manufacturing plants in the U.S. and consolidated in Mexico.
  • Resolved the inadequate supply of chilled water to molding and extrusion. Cost avoidance: of over $300 thousand per year.
  • Constructed new manufacturing facilities for respiratory care products and urological catheters and a central corrugate transfer area to process products from the focus factory.

Imed Corporation, San Diego, CA, Principal Project Engineer, 1984 - 1987

  • Supported disposable products manufacturing for a medical devices - infusion management system.
  • Installed flexible manufacturing system, bar code system, CIMS (Injection Molding).
  • Managed and implemented automation and mechanization projects for labor Intensive processes (cost savings of $500 thousand per year).
  • Designed and installed a silicone (MDX) coating equipment and dryer (explosion proof, meets hazardous environment Class I, Div. II).
  • Developed the sanitization procedure for RO/DI system, assisted technology transfer projects to off-shore sites and clean rooms certification.

Abbott Laboratories, Los Angeles, CA Principal Process Engineer, 1974 - 1984

  • Pharmaceuticals (injectables - human blood plasma fractionation products i.e. anti-hemophilic factor, prothrombin complex, albumin, PPF, anti- hepatitis HBIG, anti-tetanus, Ant-Rh Factor)
  • Implemented capital projects, capital funding requests, construction and installation.
  • Projects completed includes: New manufacturing facilities (fractionation, PTC, acetone drying (Class 10 & 100 clean room)]; tank farm; equipment systems (centrifuges, TFE, sterilizers, lyophilizers, WFI still, clean steam, CIP/SIP, chilled water, electro-dialyzers), closed-loop WFI supply system, AHF processing expansion (new westphalia centrifuges, plasma pool and cryo-harvest rooms).
  • Built an $18 million sterile filtration and aseptic filling facility for AHF - factor VIII, PTC - factor IX, HBIG, anti-tetanus, anti-Rh Factor, PPF, albumin.
  • Increased market share by $100 million per year.
  • Formerly with Research and Development Technical Operations, implemented tasks for process optimization and resolution of manufacturing problems.
  • Tested new equipment systems prior to use in manufacturing.

Honors & Publications

Credentials

  • Courses towards MBA, ISO Refresher Courses, 5S, Lean Manufacturing And Six Sigma,
  • Clinical Applications of Biomedical Engineering and Cardiovascular Physiology - UC Irvine
  • Process Quality Control and SPC, cGMP, Process Software Validation, 21 CFR Part 11

Education

  • B.S., Chemical Engineering
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