David Hardin Email & Phone Number

Greater Denver Area

Providing project engineering expertise to an engineering services provider offering multi discipline engineering services for the Life Science, BioScience, Food and Beverage and technology centered Manufacturing industries.

Fort Collins, Colorado Area

Greater Denver Area

Newalta is a leader in minimizing waste and maximizing the recovery of valuable products and resources.Contributed to design and construction of modular oilfield waste processing facilities with $9,000,000 in capital appropriations. Generated scope of work generation and tracking for tank fabrication, automation integration, and electrical installation requirements. Provided onsite technical support during construction and commissioning activities. Monitored costs, schedules and contractor management and adhered to environmental, health and safety requirements associated with new plant construction.• Daily consulted with electrical contractors on engineering design packages• Identified process shortcuts due to inclimate weather delays• Interfaced with control engineers to integrate PLC’s to monitor tank instrumentation per control strategy.

Greater Denver Area

Served as engineering lead on plant expansion projects for major pharmaceutical companies. Completed design engineering for new systems, commissioning services, new equipment procurement, project management services and technology reviews. • Managed projects with daily oversight of Johnson Controls Metasys Building Management System (BMS). o Provided trend and alarm history data to cGMP support groups including engineering management, quality, and manufacturing. Originatedand executed work orders and change management procedures for modifications to BMS parameters, graphics, and configurations; originated and executed BMS commissioning and qualification documents supporting capital projects for facility upgrades. o Handled creation of RFPs for BMS contractor demolition and installation bids, construction management, and updates to controlled documents associated with BMS system drawings.

Handled project management, process development, and staff supervision for manufacturing operation and contract manufacturing business units. Refocused business unit on contract manufacturing operations following 2010 acquisition. Oversaw technical performance of major contract manufacturing projects. Managed operations of 22,000 square foot API manufacturing facility, including 22 employees in manufacturing, process development, EH&S, and facility maintenance functions. • Managed a $2,500,000 process development and contract manufacturing project for East Coast Pharmaceutical company following major chemistry breakthrough by project research team. o Performed rapid evaluation of equipment resources associated with solvent storage, extraction, filtration, chromatography, and drying. o Procurred new equipment and re-configuration of existing equipment, along with piloting effort, leading to Phase I manufacturing effort to supply client,utilizing new chemistry pathway. o Developed economic evaluation reports on cost of goods using various scale-up scenarios. • Managed process development and Phase II production scale piloting project for West Coast Pharmaceutical company based on water based extraction, centrifugation, ultrafiltration and reverse osmosis concentration of Chinese herbs. o Evaluated different centrifugation technologies, procurement, of selected centrifuge, and installation of new GEA Process Engineering ultrafiltration and reverse osmosis skids. o Oversaw installation of clean piping system by Murphy Co. and equipment IOQ, along with origination of manufacturing documentation and initial three batch manufacturing runs to support client requirements. o Administered project costs of over $1,000,000 for fabrication, shipping, and commissioning of GEA equipment, and $1,500,000 for development and installation efforts.

Led $1,000,000 effort to review purchased technology, install process and completed three validated production runs resulting in equivalency package to support future production of product. Served as project manager for initial commercial manufacturing and process validation for Pentostatin (Nipent) following company’s purchase of technology. • Managed outsourced multi-million dollar manufacturing effort of biomass extraction and initial purification at East Coast contract manufacturer, included design and installation of major new equipment in conjunction with Penta Engineering in Charlotte, North Carolina. o Conceptualized plan to change from batch operation to continuous operation. Led $1,200,000 expansion associated with equipment, piping, instrumentation, and automation upgrades. o Originated process control schemes with the contractors’ engineering staff. o Trained manufacturing operators, quality control analysts, maintenance personnel, and operations teams to perform and understand new processing technology. Ensured full understanding of project requirements. o Increased the initial capacity associated with larger chromatography equipment. o Completed expected production increases on time and on budget.

Served on team responsible for building and installing commercial Paclitaxel manufacturing operations. Performed various aspects of process installation, qualification, and process control.