Chemical Engineering Change Management

Dennis L. Wood

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SENIOR PROCESS/PROJECT/VALIDATION ENGINEER

Process & Project Chemical Engineering / Multi-Site Operations / FDA Compliance

Change Management /Process Design & Validation / Analysis / Capital Equipment / Automation / cGMP

Leveraging a broad base of process, project and validation engineering expertise, I have reduced costs, maximized yield and productivity, enhanced quality, resolved complex manufacturing problems and authored validation documents. My experience also includes P&ID’s, process product crystallization, HAZOP, MOC’s, troubleshooting, protocols, tech transfers, validation IQOQ’s & execution, project construction management, pharmaceutical and specialty chemical manufacturing. Additional strengths include:

Launching new processes, and utilizing root cause & lean manufacturing to enhance productivity

Driving capability and capacity improvements to enable delivery of quality products

Improving operational execution through process automation and equipment improvements

Anticipating issues, developing and recommending process improvement initiatives

Led manufacturing expansion projects from start to finish. Completed projects on-time/budget.

BS in Chemical Engineering from Michigan State University, and MBA in Finance from Grand Valley State University. Known for strong leadership skills, I have successfully led, trained, and motivated multi-disciplined teams to ensure corporate and client objectives were met. Skilled in MS Office and Project.

SELECTED ACCOMPLISHMENTS

Project Engineer Expansion Project. Oxford International client, Cambrex needed to increase its production capacity. Additional reactor and vacuum capacity, plus increase existing reactors capacity improvements with additional heat exchangers and vacuum receivers.

Ensured ambitious project was completed on-time. Oversaw a new Waste Water Treatment Facility for Penta client, Owens Corning. Obtained permits, selected GC’s, prepared site, erected pre-engineer building, installed treatment system / control lab, main electric feeder, utility pipe lines, HVAC system, lift stations and equalization flow basin, plus 4000 foot underground forced main pipe to the city sanitary sewer. Completed project in 36 weeks (expected 52 weeks).

Transitioned manual to automated heating / cooling system. Penta client Lanexx project to reconfigure their chemical reactors. Obtained current P&IDs, revising for correct piping configurations including automated control / block valves, and PLC controllers. Transitioned from manual temperature control of steam, cooling water and hot oil to an automated PLC batch temperature control, saving processing time and increasing productivity.

Increased yield. Challenged to improve process for Alkermes microspheres batches. Reviewed the batch process, observed operations, and reviewed the current ANDA. Authored engineering studies, revising the process vacuum procedure used in the second drying of the microspheres. Increased yield from 12 kg to 13.5 kg of quality materials.

Boosted yield and productivity. Forty percent of Pfizer’s Lopid batches suffered from low bulk volume. Analyzed the complex crystallization method, chemical operators, and batch records that failed and didn’t fail. Revised one step in the batch process and retrained operators, eliminating low bulk volume failures.

Led manufacturing expansion project. Wyckoff Chemical needed to increase production, filtration and drying capacity, electrical power, waste-water treatment, pipe bridge systems, and warehouse capacity. Oversaw project scope, cost estimates, PFD’s, P&ID’s, schedules, construction, and more. Completed project on-time / on-budget.

PROCESS / PROJECT GENERAL MANAGEMENT DESCRIPTION

Involved from the initial Detailed Design Engineering, Project Installation Management through Process Improvement Engineering. Including Utilities (Steam, Condensate, Process Water, Compressed Air, Nitrogen, etc), from FAT, IQ, OQ and PQ.

Process operations including P&ID’s, PFD’s, Instrumentation Design & Specification, Batch Reactions, Precipitation, Separation, Extraction, Distillation, Filtration, Isolation, Drying, Milling, CIP, Steam in place, Batch Records and Equipment Cleaning Protocols, plus Engineering Studies using Lean and Statistical Methods.

Equipment includes100 L – 16000L Batch Reactors, SS/Tantalum/Hastelloy Heat Exchangers, Vacuum and Transfer Pumps, several types of Filtration Equipment, including Filters, Centrifuges and Filter Dryers. Other types of Dryers include Tray, Double Cone, Conical and Spherical. Plus Vacuum and Tempered Heating/Cooling Systems.

CAREER SUMMARY

Capital Project Manager, HIPP Workforce Solutions, Inc., 2023 to 2023

Contracted to provide Capital Project Management Engineering support for Mallinckrodt in Durham NC. The assignments were to provide managemrnt of various capital projects, including scope development and project implementation. The capital costs ranged from $50K to $1.2M, which included October Shutdown capital projects. Scheduled equipment procurement, equipment installation and commissioning/qualification.Develope and maintain budget for capital project implementation.The various capital projects included HVAC’s replacements and major repairs of solvent tanks containments including trench repairs.

Process Engineer, Oxford Global, 2022 to 2022

Contracted to provide engineering support for Regeneron inventory equipment upgrade in Albany NY. The assignment was to provide various documentation for alternative equipment that have become obsolete. The documents included alternate improved equipment, replace obsolute equipment and to stock fundtionally new equipment.

Validation Engineer, Oxford Global, 2021 to 2022

Contracted to provide validation engineering, to support ThermoFischer POROS expansion project in Chelmsford MA, to author IQOQ’s and UOP’s protocals. The assignment was to tech transfer current process operating procedures and settings from an existing facility. To develop IQOQ’s and UOP’s documents, to work with approvers, to successfully develop & execute the IQOQ’s, and also to provide technical transfer assistance to other validation team members.

Project Manager, Black Diamond Network, 2021

Contracted to provide continuing project engineering, to support CF Industries (Woodward) MOC’s capital projects. Including piping revisions, material of construction changes, steam and condensate piping revisions, process instrumentation additions or relocation, and new equipment installation.

Project Engineer, Oxford Global, 2017 to 2021.

Contracted to provide project engineering, to support CF Industries (Woodward) MOC’s capital projects. Including piping revisions, material of construction changes, steam and condensate piping revisions, process instrumentation additions or relocation, new equipment installation, removal of existing equipment with is associated piping, high and low pressure nitrogen manifolds, Turn Around 2019 projects including contractor supervision upgrading the gas burners plus refactory of the Reformer and temporary piping necessary for plant start-up.

Contracted to provide project engineering, to support Cambrex 6M capital expansion project. Including equipment installation of a 16000 L G/L Reactor, 4000 L G/L Reactor, 4 – 2000L G/L Receivers, 6 – Tantalum Heat Exchangers and 2 – Sihi Vacuum Pumps. Duties also included specifying and ordering instruments and valves, expediting equipment and instruments, P&ID reviews, supporting the Design Engineering Group, and supervision of contractors. Additionally provided project engineering design, material specification and ordering, and contractor supervision of 3 – 100k capital projects. Led team of 40.

Senior Process Engineer, Penta Engineering, 2012 to 2016. Oversaw process engineering functions including detailed design management, P&ID, and PFD for this full-service industrial engineering firm clients. Determined lines, pumps and motor size requirements. Improved manufacturing operations / productivity while reducing costs. Led team of 40.

Senior Process Engineer, Ambitech Engineering, 2011 to 2012. Verified clients new installations including pressure line tests, walk down P&ID’s, and equipment start-up / shut-down SOPs. Reconfigured steam safety relief systems. Verified current pumps sizes to ensure sufficient transfer of fuel oil from storage tanks. Led team of five engineers.

Earlier: Process Engineer, IRIX Inc.; Process Development Engineer, Alkermes Inc.; Senior Manufacturing / Process Engineer, Pfizer Inc.; Project / Process Engineer, Wyckoff Chemical Inc.; Senior Process Engineer, Bofors Nobel Inc.; Facility Engineer, Dow Corning & Pilot Plant Engineer, Michigan Chemical Corporation

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