AlfaTech Qualifications_Takeda San Diego

EXPERIENCE CONTINUTED …

*QUALITEST PHARMACEUTICALS - MECHANICAL BOD, Huntsville, AL Developed the mechanical basis of design as part of a 5-year validation master plan to meet client’s forecasted production needs. *UPSHER SMITH PHARMACEUTICALS - LITHIUM-CHLORIDE DESICCANTS DEHUMIDIFICATION SYSTEM, Wisconsin Project engineer responsible for the design and specification of lithium-chloride liquid desiccants dehumidification systems for existing tableting packaging rooms. *HANMI PHARMACEUTICALS - MANUFACTURING PLANT, South Korea Project HVAC engineer for a new GMP pharmaceutical manufacturing plant of approximately 100,000 SF including ISO 5, 6, 7 cleanrooms with cascade pressurization scheme. Designed the air handling systems, the steam reheat VAV supply boxes, the exhaust VAV boxes, HEPA filtration of supply and return, and all associated controls. Coordinated central utilities requirements for the air handlers and VAV reheat boxes with project utilities engineer. *BAXALTA - BOILER FESIBILITY STUDY, Thousand Oaks, CA Feasibility study and report to determine the structural, MEP, I&C, and permitting requirements for converting a temporary 400BHP, 150 psi steam boiler into a permanent boiler for continuous and uninterrupted supply of steam while the (2) 250BHP permanent boilers underwent NOx retrofits and testing. Mechanical and plumbing design and hazardous material consulting for wastewater treatment plant. Mechanical design including HVAC for the quality control lab and electrical rooms, and ventilation for the process rooms with corrosive sodium hypochlorite. Plumbing design included roof drains, sewer/vent, potable and non-porable water, tempered water, and natural gas. Hazardous material consulting included review of exterior tank farm, secondary containment calculations and HMIS statement. *DUPONT/GENENCOR - LAB EXPANSION, Palo Alto, CA Project mechanical engineer for 20,000 SF bioscience lab expansion including Granulation, Fermentation, Large/Small Scale Recovery suites built to food grade standards. HVAC and laboratory scrubbed exhaust design including custom local exhaust hoods and wet benches designed based on ACGIH and ASHRAE standards. Process piping and utility piping design for process equipment. *BIOMARIN - HAZMAT STORAGE, San Rafael, CA Design of safety storage hazmat bunkers for large chemical volumes. Design of associated exhaust and makeup air design. *BIOMARIN - WASTEWATER TREATMENT FACILITY DESIGN, San Rafael, CA

*ATUM-BIO - CGMP TISSUE CULTURE SUITE, Newark, CA Process piping and plumbing design for a 7,000 SF tissue culture CGMP suite with Grade C/ISO 7 & Grade D/ISO 8 cleanrooms. Heating hot water boiler plant design. Plumbing and process piping systems including CGMP CO2, CO2, liquid nitrogen distribution system for cryogenic freezers, central DI water system, Milli-Q systems, sewer/vent, potable cold/hot/tempered water, and natural gas. *GRIFOLS – MAMMALIAN CELL CULTURE LAB EXPANSION, Emeryville, CA Project mechanical and plumbing engineer for a 10,000 SF mammalian cell culture lab expansion. The HVAC systems were designed for the CNC suites with constant volume air handling units set up for cascade pressurization scheme with reheat coils, ducted HEPA filters, and low wall return. Prepared HVAC specifications for turnkey cold room freezers. Biological safety cabinets were utilized for sensitive containment processes. Plumbing for the lab include purified water, cell waste drainage system to an existing inactivation treatment system, CO2, O2, and N2 gases. *CONFIDENTIAL CLIENT - PHARMA MANUFACTURING FACILITY RISK ASSESSMENT, North Carolina On site field survey and risk assessment of aging infrastructure at 1M+ SF manufacturing facility of IV and irrigation solution products. Survey of critical utilities supporting the cGMP manufacturing facility including raw water wells, fire protection loop, distillation stills, purified water systems, cooling towers, plant/process compressed air, wood fired boiler, steam, chilled water, cooling pond water. Work closely with plant operators, plant engineering manager, and capital expenditures team to prioritize risk and define action plant to address critical risks. *THERMOFISHER - OLIGO LAB RECONFIGURATION, Pleasanton, CA Mechanical engineer for retrofit of Oligo lab with new walk-in fume hood and solvent storage cabinets and associated solvent dispense (ACN, deblock) and solvent waste process piping systems.

COSSAIRT-LEUNG, LEANNE

*denotes work performed with previous firm.