)roject Engineer

Dennis L. Wood

Greensboro, NC *****

Summary:

SENIOR CAPEX PROJECT / PROCESS / MAINTENANCE MANAGER & VALIDATION ENGINEER

Capex Project, Process, Operations, Maintenance & Validation Chemical Engineering / Multi-Site Operations / FDA Compliance / Change Management / Process Design & Validation / Analysis / Capital Equipment / Automation / API cGMP Facilities.

Leveraging a broad base of capex projects, detailed process design, operations, maintenance and validation engineering expertise, I have reduced costs, maximized yield and productivity, enhanced quality, resolved complex manufacturing problems and authored engineering studies and validation documents. My experience also includes detailed design P&IDs, ISOs, process product crystallization studies, HAZOP, MOCs, PM reliability, troubleshooting, protocols, tech transfers, Kneat validation IQs, OQs & execution, project construction management, pharmaceutical and specialty chemical manufacturing. Additional strengths include:

Launching new processes, and utilizing PI, SCADA, root cause, lean and statistical manufacturing analysis to enhance productivity/quality.

Driving capability and capacity improvements to enable delivery of quality products

Improving operational execution through process automation, equipment improvements and PM reliability.

Anticipating issues, developing and recommending process improvement initiatives

Lead manufacturing expansion projects in medium to large scale pharmaceutical facilities from start to finish. Completed projects on time / on budget.

Education:

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. My skills include MS Office and MS Project.

SELECTED ACCOMPLISHMENTS:

Capex Project Engineer Manager. Oxford International client, Cambrex needed to increase its API cGMP production capacity. Additional reactors and vacuum systems, plus provide existing reactors with capacity improvements with additional heat exchangers and vacuum receivers. Overall Project Capital cost 20M – 25M.

Ensured the ambitious project was completed on time. Oversaw a new Wastewater Treatment Facility for Penta client, Owens Corning as a Site Project Engineer Manager. Obtained permits, selected GC’s, prepared site, P&IDs, ISOs, erected pre-engineer building, installed treatment system/control lab, main electric feeder, utility pipelines, HVAC system, lift stations and equalization flow basin, plus 4000-foot underground forced main line to the city sanitary sewer, with validation and commissioning. Completed project in 36 weeks (expected 52 weeks).

Transitioned manual to automated heating/cooling system. Penta client Lanexx project to reconfigure their chemical reactors' automated temperature control system as a Chemical Detailed Design Process / Project Engineer. Revised current P&IDs, edited 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.

Increase yield. Challenged to improve the process for API cGMP Alkermes sterile facility microspheres batches as a Senior Process Chemical Engineer, including validation and commissioning. Reviewed/edited the batch process, observed operations with SCADA, statistical analysis and review of the current ANDA. Troubling by the delivery of process solutions by authorizing engineering studies, revising the process, vacuum procedures used in the first and second drying procedures of the microspheres. Increased yield from 12 kg to 13.5 kg of quality materials (Note: max theoretical yield 15.0Kg).

Boosted yield and productivity. As a Senior Process/Manufacturing Manager Chemical Engineer, forty percent of API cGMP Pfizer’s Lopid batches suffered OOS from low bulk volume. Analyzed the complex crystallization method, chemical operators, and batch records that both failed and passed. Revised one step in the batch process, retrained operators, eliminating OOS low bulk volume failures, using PI, root cause and statistical analysis. Plus provided front-line manufacturing support.

Led manufacturing expansion project. As a Senior Project/Process/Manufacturing/Maintenance Chemical Engineer for Wyckoff Chemical, required to increase production, filtration and drying capacity, electrical power, waste-water treatment, pipe bridge systems, and warehouse capacity. Determined equipment specifications such as reactors, vessels, heat exchangers, HVAC cooling systems, pipelines, pumps and motor size requirements. Improved manufacturing operations/productivity / PM reliability and utilities while reducing costs. Oversaw project scope, cost estimates, PFD’s, P&ID’s, schedules, PM reliability, construction and maintenance. 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, Commissioning and Validation. Including Utilities (HVAC systems, Steam, Condensate, Process Water, Compressed Air, Nitrogen, etc), for FAT, IQ, OQ and PQ.

Process operations include P&IDs, PFDs, ISOs, Instrumentation Design & Specification, and the use of the Stage Gate method for Project installation scheduling. Type of Batch Reactions: Precipitation, Separation, Extraction, Distillation, Filtration, Isolation, Drying, Milling, CIP, Steam in Place, Batch Records, PM reliability, and Equipment Cleaning Protocols, plus Engineering Studies using Root Cause Analysis, Lean and Statistical Methods.

Equipment specifications include 100 L – 16000L Batch Reactors, SS/Tantalum/Hastelloy Heat Exchangers, HVAC systems, 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.

PROFESSIONAL EXPERIENCE:

Pfizer, Andover, MA (Biopharma Industry) Jun 2026 – Sept 2026

Project Manager

Contracted to provide Project Management Engineering support for EMU cGMP Pfizer facility in Andover MA.

The assignments were to provide management of various capital projects, including project scope, description, commissioning and project field management.

The capital costs ranged from $50K to $3M.

Reviewing project drawing, walkdowns, submittals and commissioning/qualification.

The various capital projects include Building B Office Renovation Phase 1 & 2, Production rooms HVAC reclassifications, and developing PMs for five-year Work Order plans to inspect 9 Building areas of Sanitary Water underground piping.

Siegfried, Pennsville, NJ (Pharma Industry) Jun 2025 – Jan 2026

Capital Project Manager

Contracted to provide Capex Capital Project Management Engineering support for the API cGMP Siegfried facility in Pennsville NJ.

The assignments were to provide management of various capital projects, including project scope, description, cost estimate, budget, accruals, quotes, vendor/contractor selection and project field management.

The capital costs ranged from $50K to $2M, which included September Shutdown capital projects.

Scheduled equipment procurement, equipment installation and commissioning/qualification.

Develop and maintain a budget for capital project implementation.

The various capital projects include HVAC system replacements, various SS piping and pumps upgrades, Hastelloy Heat Exchangers, and TCU skids.

Astra Zeneca, Dallas, TX (pharma industry) Sep 2024 – Nov 2024

Senior Process Engineer

Contracted to provide process production and technical support in an aseptic environment for Astra Zeneca.

The assignment was to provide various process management including documentation review, data analyst, troubleshooting, working with cross functional teams, automation, operations, quality, maintenance, instrumentation and validation.

The goals were to improve and optimize existing process procedures, maintain production, quality, and yield. Additionally, improvement in instrumentation, process control and equipment reliability.

Mallinckrodt, Durham, NC (pharma company) April 2023 – Nov 2023

Capital Project Manager

Contracted to provide Capex Capital Project Management Engineering support for API cGMP Mallinckrodt facility in Durham NC.

The assignments were to provide management of various capital projects, including project scope, description, cost estimate, budget, accruals, quotes, vendor/contractor selection and project field management.

The capital costs ranged from $50K to $1.5M, which included October Shutdown capital projects.

Scheduled equipment procurement, equipment installation and commissioning/qualification.

Develop and maintain a budget for capital project implementation.

The various capital projects included HVAC systems replacements and major repairs of solvent tanks, containment, and trench repairs.

Led teams of 20 – 40.

Regeneron Pharmaceuticals, Albany, NY (pharma company) Aug 2022 – Dec 2022

Project Engineer

Contracted to provide engineering support for API cGMP Regeneron sterile facility inventory equipment upgrade in Albany NY.

The assignment was to provide various documentation for alternative equipment spare parts that have become obsolete.

The documents included alternate improved equipment, preventive maintenance reliability, replacement of obsolete equipment and stock functionality of new parts.

ThermoFisher, Chelmsford, MA (pharma company) Sep 2021 – Jul 2022

Senior Validation Engineer

Contracted to provide validation engineering, to support API cGPM ThermoFisher facility POROS expansion project in Chelmsford MA.

Duties included P&IDs reviews/edits & red line walk downs, authored IQs, OQs and UOPs protocols.

Overall Project Capital cost 120M –125 M.

The assignment was to complete a tech transfer of the current process operating procedures and process settings from an existing facility.

To develop (Kneat) IQs, OQs and UOP’s documents, work with approvers, successfully develop & execute the validation and commissioning of IQs, OQs, CAPA.

Risk, Hazard analysis. Plus provide technical transfer assistance to other validation team members.

CF Industries, Woodward, OK, Feb 2021 – Sep 2021

Capex Project Manager

Contracted to provide continuing Capex Project Engineering, to support CF Industries (Woodward) capital projects.

Including piping revisions, MOC changes, steam and condensate piping revisions, process instrumentation additions or upgrading, PM reliability and new equipment installation.

Led teams of 15 – 25.

CF Industries, Woodward, OK, Jan 2017 – Jan 2021

Capital Project Engineer Manager

Contracted to provide Capex Project Engineering to support CF Industries (Woodward) capital projects.

Including piping revisions, MOC changes, steam and condensate piping revisions, process instrumentation additions or relocation, new equipment installation, preventive maintenance reliability, removal of existing equipment with its associated piping, high/low pressure nitrogen manifolds, determined specifications of equipment such as vessels, heat exchangers, HVAC cooling systems, pipelines, pumps and motor size requirements.

Improved manufacturing operations/productivity and utilities while reducing costs. 2019 TA projects including contractor supervision upgrading the gas burners plus refectory of the Reformer, temporary piping necessary for plant start-up, validation and commissioning.

Led teams of 15 -25.

Cambrex, Charles City, Iowa (pharma company) March 2017 – Oct 2017

Capex Project Manager

Contracted to provide Capex Project Engineering Management to support Cambrex's two $6M capital expansion projects.

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&IDs & ISOs reviews, supporting the Design Engineering Group, and supervision of contractors.

Additionally provided project engineering design, material specification and ordering, contractor supervision of $3k – $10M capital sub-projects costs, validation and commissioning.

Led teams of 20 - 40.

Penta Engineering 2012 to 2016

Senior Process/Project Engineer

Oversaw process engineering functions, including detailed design management, P&IDs, ISOs and PFD for this full-service industrial engineering firm’s clients.

Determined equipment specifications and calculations for reactors, vessels, heat exchangers, HVAC cooling systems, pipelines, pumps and motor size requirements.

Improved manufacturing operations/productivity and utilities while reducing costs.

Led teams of 20 - 40.

Ambitech Engineering 2011 to 2012

Senior Process/Project Engineer

Verified client’s new installations include pressure line tests, red line walk-down P&IDs, ISOs, and equipment start-up / shut-down SOPs.

Determined equipment specifications and calculations for reactors, vessels, heat exchangers, HVAC cooling systems, pipelines, pumps and motor size requirements.

Improved manufacturing operations/productivity and utilities while reducing costs.

Reconfigured steam safety relief systems.

Verified current pump sizes to ensure sufficient transfer of fuel oil from storage tanks.

Lead a team of five engineers.

Alkermes Inc., Wilmington, OH (pharma company)

Process Development Engineer

Responsible for the development and scale-up of new and existing processes in the sterile facility Manufacturing Lines 3, 4, 5 and the Pilot Plant.

Processes include Vivitrol, Risperdal and Exenatide LAR.

Author required engineering studies documents, design and develop experimental protocols.

Troubleshoot technical problems, design ways to prevent failures.

Participate/plan process validation.

Wyckoff Chemical, South Haven, MI (pharma company)

Senior Process/Project/Maintenance/Operations/Plant Engineer

Verified new installations include pressure line tests, walk down P&IDs, ISOs provided front line floor support, commissioning, validation and equipment start-up / shut-down SOPs. Determined equipment specifications such as reactors, vessels, heat exchangers, HVAC cooling systems, pipelines, pumps and motor size requirements. Improved manufacturing operations/productivity and utilities while reducing costs.

Provided Maintenance Manager support for the technicians' training in mechanical seals replacement, centrifugal pump repairs, instrumentation calibrations, purchasing additional maintenance equipment, preventative maintenance reliability and scheduling yearly shutdown maintenance projects.

Earlier: Senior Process Engineer, IRIX Inc.; Senior Project / Operations / Process Engineer, Pfizer Inc

Contact this candidate