Richard Davy Email & Phone Number

Leading Process Engineering on Front End Engineering Design for AUD$750 million Ammonium Nitrate Facility

HVAC Commissioning and Qualification Manager leading the start-up, commissioning and qualification of all HVAC systems and associated manufacturing clean room facilities for the US$500 million GlaxoSmithKline Bulk Vaccine Manufacturing Project, Singapore. Responsible for leading a team of engineers, sub-contractors and specialists through the planning, preparation and execution of Commissioning and Qualification, taking the facilities through from mechanical completion, commissioning and qualification to final handover to GSK operations.

Commissioning and Qualification Manager Led the commissioning, testing and qualification of manufacturing facilities and HVAC systems for US$200m Novartis Singapore Manufacturing Project [NPSM]. Developed the commissioning and qualification master plan for all HVAC systems, manufacturing clean rooms and associated utilities. Developed and maintained the schedule and resource plan, with responsibility for planning and coordinating all activities to achieve critical goals and milestones within the overall project schedule.Produced and implemented all commissioning and qualification documentation, executed commissioning and qualification activities and managed document systems through to final approval and handover to Novartis quality department. NPSM documentation was subsequently adopted as Novartis global standard templates for all HVAC qualification. Managed a multi-disciplinary team of sub-contractors, engineers and specialists to complete the start up, testing and qualification of all HVAC systems and related clean rooms. Completed the project against an aggressive schedule to ensure that facility was ready for production activities to begin Quarter 4 2007.

Project Managed the Front End Engineering Design [FEED] for A$15 million project to modify and upgrade an existing FDA regulated production facility for GlaxoSmithKline in Singapore. The upgrade enabled the manufacture and qualification of a new Active Pharmaceutical Ingredient.The completed design included process design, control system specification, design and specification of new processing equipment, people and material flows, electrical zoning, segregation of the facility to enable concurrent manufacturing of unrelated products, integration of the new equipment and processes with existing processes and utilities, process and instrumentation diagrams, plant layouts, piping layouts and generation of a ±10% cost estimate. Executed the Front End Engineering Design for a complete new A$10 million cGMP manufacturing facility for a company based in Melaka, Malaysia. The new facility was designed to replace the companies existing aging facilities, increase manufacturing capacity and improve product quality. The design incorporated blending, filling and packaging operations for liquid and cream products, and an aseptic facility for the manufacture of sterile eye drops.Provided GMP and Validation consultant service to a Malaysia based secondary pharmaceuticals manufacturer engaged in the design and construction of a new manufacturing facility. Responsible for the overall validation planning and documentation, GMP design reviews, conducting GMP training, advising client on best practice and providing engineering input on the design of critical systems including HVAC, Purified Water and clean gases.

Completed the Front End Engineering Design for a complete new A$13 million Greenfield facility to manufacture a liquid Active Pharmaceutical Ingredient [API]. Process design involved multi-step synthesis, liquid-liquid extraction and batch distillation. The scaled up process was designed to operate as a semi continuous plant with continuous distillation and solvent recovery. The overall facility design included raw material and finished goods handling, hazardous materials handling, laboratories and offices, HVAC and air filtration, waste collection and treatment, building design, site layout, equipment and facility layout drawings and ±20% capital cost estimate.Carried out the complete concept design for a new green field A$110 million biological manufacturing facility to manufacture an API based on e-coli fermentation and recombinant protein process. The process design included scale up from the gram scale to 4000kg/yr, mass and energy balances, equipment selection and sizing, utilities assessments, bulk handling for raw materials, waste collection and waste treatment strategies. The facility design included warehousing, laboratories and offices, facility layout drawings, containment requirements and strategy, HVAC, and waste treatment technologies. The concept was presented together with estimated capital and operating costs to support the client’s strategic planning requirements.Headed the cGMP Validation team for a new facility for the manufacture of diagnostic kits. Facility was designed to handle live biological agents and incorporated Biological Safety Level 2 and Level 3 manufacturing suites. Encompassed cGMP design strategies, facility layout and design, validation planning, detailed user requirement specifications and functional specifications, design qualification of the facility, preparation of all facility qualification documentation and execution of Installation Qualification and Operational Qualification.

Managed the operations and led the process engineering for a FDA / cGMP regulated Pharmaceutical Pilot Plant to ensure successful scale up, transfer and validation of multi-step drug synthesis products from laboratory to full production plant. Oversaw all pilot plant activities to achieve production and cost targets, guarantee plant safety and ensure compliance with cGMP and FDA regulations through correct implementation of operational, validation and quality procedures.Generated and implemented plant procedures, standard operating procedures, process batch sheets and validation documentation. Planned and supervised the work of the Pilot Plant operations, maintenance and support teams to achieve plant technology transfer and production goals within tight time and budgetary constraints. Directed and executed the capital projects program for the pilot plant. Managed, engineered, constructed, commissioned and validated projects to expand the processing capabilities of the facility and support manufacturing activities. Engineered and installed a new US$2 million cryogenic reaction facility in pilot plant. Responsible for the process design, engineering and construction of the facility incorporating fully serviced reactor and liquid nitrogen cooling system. Successfully started up commissioned and validated the facility.

Completed a comprehensive review of the emergency venting systems for a polymer production plant handling highly volatile and flammable solvents. The review encompassed detailed assessment of existing vent system design, calculation of vent capacity using DIERS methodology and full quantitative risk assessment of existing process safety systems and interlocks.Presented detailed and comprehensive proposals for remedial action to bring the plant into compliance with UK Health and Safety Executive [HSE] regulations. The client action plan was subsequently approved by the HSE regulators.

Successfully completed the fast track process engineering design and implementation of a US$15 million project to install a new fibre chemical treatment facility. Scaled the process from 60-tpw pilot plant to 400-tpw production unit. Generated detailed process design, mass balance, energy balance, P&IDs, equipment data sheets, instrument data sheets and piping specifications. Designed the plant control system and produced detailed functional specification to facilitate programming of PLC/SCADA control software. Led plant team in execution of factory acceptance testing, verification and commissioning of software systems.Led the project team through detailed safety risk assessment, Hazard-Operability, Hazard-Analysis and job safety studies. Planned all commissioning activities, produced detailed commissioning documentation and led multi disciplinary team through to successful on-time start up of project.Delivered the project on time and within budget against very challenging schedule.

Process and Project Engineer for five-specialty chemical manufacturing plants employing batch and continuous processing, spray drying and solvent recovery. Managed multiple project portfolios with combined capital of over US$8 million. Successfully completed a diverse range of capital projects up to US$2 million in value.Developed and designed a novel process to reduce plant environmental impact through the recovery and re-use of aniline and xylene from chemical plant effluent. New recovery process reduced capital spending requirements by US$2 million compared to traditional liquid-liquid extraction technology, recovered raw material to a value of US$100K p.a. and ensured plant compliance with environmental permits.Designed and Project Managed the installation of a new US$1.5 million automated drum filling and palletisation facility for highly corrosive detergent additives. Designed and installed a new US$2 million raw material storage and transfer facility for the bulk handling of molten Phenol. Design was subject to high regulatory scrutiny and all phases of the project were subjected to comprehensive safety risk assessment, Hazard-Operability, Hazard-Analysis and job safety studies.Led the design safety reviews for a batch reactor system employing highly flammable and toxic reagents and a hydrogenator. Reviews included evaluation of emergency venting and relief system design, safety interlock risk assessments and classification, Control and Automation System review, Hazard and Operability review.Completed a portfolio of environmental and energy reduction projects for production units. Projects included reactor off gas incineration and heat recovery, solvent vent reduction and recovery, water reduction and recycle and effluent toxicity reduction. Prepared plant remediation action plans for submission to United Kingdom Environment Agency.

Designed chemical plants in borosilicate glass for use in high purity and highly corrosive processing environments. Provided customer sales and technical support services to the fine chemicals and pharmaceutical industry