Steven E. James, Pe, Pmp Email & Phone Number

Thousand Oaks, Ca, Us

Provide project/program/portfolio management, support, & oversight for:+ Test Method Development+ Test Method Transfers+ Technology TransfersTeach engineers how to effectively use MS Project w/ resource-loaded schedulesUpdate / maintain resource loading tracking system for entire project portfolio (>200 projects)

Aurora, Ohio, Us

Write client proposals, develop MS Project schedules, coordinate project execution.

Thousand Oaks, Ca, Us

CMCi Project Manager for Combination Device Development. Manage phased device development efforts, including schedule development, project communications, and device design controls for late-stage and life cycle management combination device development Familiar with pre-filled syringes, auto-injectors, and electro-mechanical devices. Also contributing to the development of an enterprise project portfolio management system.

Raleigh, North Carolina, Us

Temporary consulting assignment developing documentation and executing IQ/OQ/PQ protocols for clients in the biotechnology and medical device industries.

Stuttgart, Baden-Württemberg, De

Write proposals, led project efforts, customer relations.- PM for automation projects involving Allen-Bradley Rockwell systems- PM for validation of Siemens XFP MES System- Contributed to proposals for new business development

Aberdeen, Gb

Managed offsite office and program of 50+ seconded engineers and project managers dedicated to serving the engineering needs of a major oil company operating in California's San Joaquin Valley. Accountable for overall work quality, project performance, human resources, and client relations.►Successfully turned around a program that was failing and not meeting client expectations prior to my arrival.►Conceived and led the creation of a checklist based new employee onboarding program to enable new team members to quickly become productive. This approach has now been copied to other Mustang Engineering locations.►Conceived and led the implementation of written job descriptions for recruiting new team members to ensure that their qualifications were a match for client needs.►Conceived and led the creation of workflow documentation to clarify work processes for team members.►Conceived and led the creation of consolidated documentation of team members' capabilities to increase our client's understanding and desire to use our resources.►Conceived and led the implementation of simple checklist based drawing QC approach to decrease drawing errors and improve our client's perception of our work quality. This approach has been praised by our client and has been copied to two other Mustang Engineering divisions.►Conceived, designed, and implemented a large multi-user Microsoft Access database for organizing project management information which allowed for program level reports such as resource utilization.►Conceived and implemented a streamlined timesheet approval process that reduced paperwork and the number of client signatures required.

Preparation of new project proposals for engineered oilfield equipment skidsCoordination of six engineering resources for oilfield projects►Preparation of customer status reports►Led internal meetings►Drive the completion of project deliverables and the resolution of technical issues

Successfully managed $1.1 million energy efficiency project for a Texas brewery: new lighting, updated refrigeration controls, updated air compressor controls, new boilers.►Designed the new boiler piping—zero problems discovered during commissioning.►Client very satisfied & requested that I be the PM for a follow-on project.Co-developed and project managed a $3.4 million project comprised of an anaerobic digester and biogas recovery system.

Pomona, Ca, Us

►Execution of Cleaning Validation Protocols►Led execution of Clean-Out-Of-Place Validation Protocols►Completed Engineering Studies to facilitate process improvements

Utilities study for a petroleum refinery Captured process data from OSI PI databaseProcess design and instrumentation for 2 biodiesel plantsProcess design and project management for biogas plants Amine unit, glycol gas drying, PSA gas purification, biological Hydrogen Sulfide destructionProcess development for gasification plant Updraft and fluidized bed systemsChemCAD process simulationImplemented online project collaboration systemMS Access database development Automated bill of materials generation Automated drawing checks

Deerfield, Illinois, Us

Support of facility shutdown projects for formal facility shutdown.Project management of modifications to existing reverse osmosis skid to improve CIP process.Development of exhaust duct improvements for liquid nitrogen flash freezing for lyophilization.

Us

Scope development and conceptual design of a relocated & upgraded Clean-Out-Of-Place parts washing area for cosmetics manufacturing facility.Scope development and conceptual design of modifications to the wastewater treatment process to make it operate more robustly. Created P&ID for system using AutoCAD.Scope development and project management of installation of a new 150 gpm pH Adjustment System. Got system installed and operational within 60 days of management request.Technical input for a new $2 million purified water system.Resolved pumping issues with product totes costing over $10,000 each in repairs with a $300 part.

Prepared feasibility study of petroleum waste disposal upgrades for major refinery.Scaled-up the design of a 7 column distillation train and batch reactor for a manufacturer of water treatment chemicals. Used ChemCAD process simulator to facilitate rapid design changes.

Foxborough (Foxboro), Massachusetts, Us

Managed execution of various Emerson DeltaV DCS system implementations for biopharma clients.Created resource-loaded Microsoft Project schedules that were used for tracking progress.Interfaced with clients, ran meetings, and prepared status reports.Prepared detailed project financial projections to track estimated costs at completion.Redesigned and reimplemented major MS Access databases used for commissioning.

Boston, Ma, Us

Provided key insights to the cause of leaking product drums. Implemented solution I developed.Authored user documentation of recipes for new DeltaV DCS system implementation.Provided periodic analysis of batch historian data for troubleshooting production issues.

Burlington, Ma, Us

Successfully completed the redesign of 9 chromatography systems 2 weeks prior to the due date.

Managed the design and implementation of $1.3M of Clean-In-Place upgrades to eight pharmaceutical pilot plant work centers from start to finish.Completed a detailed estimate, process model, process design, and process validation of a $600K sulfuric acid distribution system upgrade.Completed the process design of a $700K pharmaceutical product unloading facility in Puerto Rico.Specified and used an ultrasonic flowmeter to complete an operating parameter characterization of an industrial rotary dryer.Designed and coordinated the replacement of a lab water distribution system.Coordinated the completion of detailed estimates to upgrade jacket service, condenser service, and instrumentation for a glass lined reactor used for the production of active pharmaceutical ingredients.Completed a detailed cost estimate and process design for a $75K header extension for a liquid nitrogen distribution system.Designed and implemented an award-winning Microsoft Access database to replace EarthTech's outdated spreadsheet timesheet system.

Us

Served as Fru-Con's Project Engineer for a glycerin plant expansion project for a northern Ohio client using vacuum distillation, wiped-film evaporation, multi-pass condensers, and a steam-jet vacuum system.Stepped in as a Fru-Con cleanroom consultant for a semiconductor client and restored faith in Fru-Con's ability to make a cleanroom addition functional. Reduced airborne particulate levels to meet client requirements within one day of my arrival at the client's plant.Served as Project Engineer for a "Pre-Engineering study" to develop scope and cost for an injection molding plant expansion project in western Ohio.Successfully worked as both Project Environmental Engineer and Process Engineer for a multi-firm consortium working on a half billion dollar paper plant construction project.

Supervised the production of fiber optic coatings while the normal production supervisor was on vacation.Designed and managed the implementation of a new production line for the fiber optic coatings production plant. My improved design cut heating water usage by 50%.Developed the preventative maintenance program for fiber optic coatings in order to meet ISO 9000 requirementsDeveloped the production planning approach for fiber optic coatings production; planned and initiated raw materials purchases for each month of productionDeveloped a test method for determining how effectively pigments are wetted out in ink dispersions Identified and eliminated a source of coating contamination in the compressed air supply by implementing a new desiccant dryer system.Re-wrote over 15 manufacturing procedures to eliminate product and process dependencies

Developed and implemented new processes and procedures for cleaning and inspection of silicon wafersPlayed an instrumental role in the specification and design of a new 1 million dollar state-of-the-art ultrapure water system--defined project scope and functional specs.Developed and implemented improvements to Product Engineering's work order development process that resulted in a 50% reduction in preparation timeDeveloped and implemented data acquisition software to expedite cleanroom particle measurements which reduced data processing time by 75%Designed and implemented a modification to inspection lighting systems that reduced emitted airborne particles by 99%Identified and corrected a weakness in the sanitization procedure for the ultrapure water system which resulted in cutting the downtime requirement by 36%Designed and implemented the incoming inspection program for cleaning chemicals in order to meet ISO 9000 requirements

Supervised installation of a new batch reactorDesigned and supervised the installation of the upper deckPerformed a energy analysis of the reactor and sized a used heat exchanger to be connected to the reactor's jacketSpecified piping for the reactorFacilitated the use of MathCAD in the above energy analysis and piping specificationCoordinated and troubleshooted installation of electronic motor controllers for two industrial centrifugesCoordinated installation of a retrofitted batch distillation columnSpecified piping and a pump for installation of a backup boiler fuel system

Columbus, Ohio, Us

Assisted in performing Preliminary Hazard Analysis studies at clients' chemical plantsLearned how to lead HAZOP studiesPrepared drawings (PFDs, graphs, charts) for courses using CADD and drawing packagesMaintained material properties database for use in Primatech's software productsProduced technical information for use in Primatech's software products and coursesProduced the software requirements documents for two new Primatech software productsAssisted in high-level testing of Primatech's software productsPrepared documents containing high-level software testing proceduresDesigned and implemented a Paradox database for managing customers' suggestions and problem reports on software produced by Primatech

Bs, Chemical Engineering

Distinguished Toastmaster Credential, Public Speaking

Certificate, Competent Leader Credential, Public Speaking

Certificate, Competent Toastmaster Credential

Certificate, Process Systems & Piping Course

Team Coach, Team Management Leadership Program Coaching

Participant, Team Management Leadership Program 2

Participant, Team Management Leadership Program 1

Participant, Kepner-Tregoe Analytic Troubleshooting

Participant, Self-Expression & Leadership Program

Certificate, Managing Multiple Projects

Participant, Zenger-Miller Frontline Leadership