SUMMARY:

• Accomplished, personable, positive, self - driven, high level of independent initiative, technical professional with 17+ years of experience and skills in plant construction, infrastructure projects, pharmaceutical validation, regulatory compliance, process industries, petro chemical, chemical, heavy manufacturing, consulting, engineering standards, government contracts, team leadership, strong customer facing skills, field construction, process improvement and innovative money saving solutions for clients.
• Project management/engineering, manager of teams (up to 65 workers), engineering calculations/review/design/best practices, equipment specification, system design, submittal/technical reviews, project execution plans, scope, time/cost estimates, resource allocation, risk analysis, piping and instrumentation diagram (P&ID) walk downs, tagging, calibration, field installation plans, work installation/packages, construction electrical/mechanical systems, capital expansion, infrastructure upgrades, procedure, SOP and protocol authoring/execution, validation, start-up/commissioning, preventative/corrective maintenance, equipment monitoring, root cause failure analysis, corrective actions, process mapping and process improvement.
• Supervised activities to ensure proper controls (administrative, records, SOP’s and physical) were in place to safely remove equipment, piping and structures which had one or more of the following hazards: irradiation, residual radioactive contamination, asbestos, lead or toxic chemical(s).
• Provided cradle to grave coordinated of activities such as lay down areas, permits, regulatory compliance, transportation, remediation, final disposition if landfilled, local and State notification and air clearance.
• Business unit operation, sales, sales management, P&L responsibility, recruiting, training, mentoring, coaching, motivating other to action, liaison building strong working relationships with all parties involved (stakeholders, customers, Confidential level management, department heads, teams and production workers), contract negotiation, procurement coordination, vendor oversight, team building, VPP/safety champion and consensus building.

COMPUTER SKILLS:

Microsoft Office and MS Project 2010, Windows 7, XP and Vista, SharePoint, Notes, Passport, CHAMPS, DCMS, MySQL, AutoCAD, Autodesk Design Review, MATHCAD, Adobe Acrobat, Corel Draw, PaintShopPro, Newforma.

RELEVANT ENGINEERING AND INDUSTRIAL EXPERIENCE:

Sr. Validation Engineer

Confidential, Lincoln, NE

Responsibilities:

• Providing validation support for a 1MM+ project to replace 220 controllers, servers, work stations and various network infrastructure and room BMS setting decision trees to support GMP and non-GMP areas of an OTC manufacturing facility.
• Computer System Validation for Siemens and Andover BMS. Authoring, review, modification of Validation Plan(VP), User Requirement Specifications( Confidential ), Functional Specifications (FS), periodic review of SOP’s, Change Control ( Confidential ), Corrective and Preventive Action (CAPA) close out, Failure Mode Effects Analysis ( Confidential ), Installation, Operational, Performance, Qualifications (IQ, OQ, PQ) and other validation / engineering activities.
• Daily interface with vendors, engineering, project management, stakeholders and facilities engineering.

Project Manager / Site Representative

Confidential, Sunnyside, WA

Responsibilities:

• Responsible for project and construction management, facility expansion, developing designs based upon company and user requirements.
• My duties include budget development, preparing capital project funding request data, specification and scope of work authoring, permitting, regulatory compliance, subcontractor relationship and oversight, vendor relations, contract negotiations and construction plan adherence, scope, bid approval, contract compliance, and safety for a $12,500,000+ site expansion.
• Manager contractors and outside vendors for safety, quality of work and schedule adherence.
• Work included such as, but not limited to, the following; geotechnical drilling, piping, civil road work, geotechnical, surveying, utility location, auger renovations, hoist repairs, electrical upgrades, concrete work, tank design and installation, lifts by large cranes, design of several buildings up to ~15,000 SF, mechanical, electrical and plumbing design, lab layout, process waste system, solids separator, evaporative water pond cleanout/design/expansion, tank and line passivation.

Sr. Validation Engineer

Confidential, Saint Louis, MO

Responsibilities:

• Validation engineering and IQ, PQ, OQ protocol authoring for the following systems; Building 260 Utilities, Service Water, Glycol Hot Water, Cold glycol, Reheat Hot Water, Deionized Water, USP Purified Water, Compressed Air, Vacuum, Nitrogen, Plant Steam, High Pressure Clean Steam, Air Handling and Emergency Exhaust system, Reslurry (and other process tanks), Bag Filter and an Oxycodone Belt Filter Press.
• Daily interface with engineering, project management, stakeholders and facilities engineering.

Project Manager / Site Representative

Confidential, Woodland, CA

Responsibilities:

• Responsible for construction management, construction crews of over 65 workers, budget expenditures, payment approval, permitting, subcontractor oversight, vendor relations, contract negotiations, specification and construction plan adherence, scope, bid approval, contract compliance, design and safety for an $11,000,000+ site expansion involving over 16 buildings, three bulk storage tanks (50,000 gallon water, 9,300 gallon Reverse Osmosis water and 5,500 gallon liquid propane tank), mechanical, electrical and plumbing infrastructure.
• The equipment and systems installed included: laboratory Fume Hoods, a Lyophilizer, two small lab Autoclaves, 355,000 BTU per hour Boiler, large Autoclave, Environmental Chambers, Pathology laboratory facilities, 500 GMP Fire Suppression system, 8.8 GMP Reverse Osmosis system, site card readers and security system, surveillance cameras, network infrastructure (WAN, WAP, LAN, Fiber Optic / CAT 5 cable, VOIP phone system), High Pressure Sodium lighting systems, mechanical infrastructure (HVAC, Condensers, Refrigeration, material handling, material processing) electrical infrastructure (Switch Gear, 3 Emergency Generators, Control Panels), plumbing infrastructure (Water, Waste Water, RO Water, Lab Waste, Site Runoff).
• Managed Site Safety orientation and spot inspections to provide over 30,000 incident free man hours while delivering on time results.
• Supervised demolition, geotechnical drilling, weekly Storm Water Pollution and Prevention inspections, asbestos testing and environmental clearance compliance.

Sr. Validation Consultant

Confidential, Boston, MA

Responsibilities:

• Project/validation engineering support, SOP, protocol authoring/execution and contractor liaison for a Consent Decree Remediation of QC Laboratory Facilities, Equipment and Utilities comprised of the following systems; Electrical Power Distribution, Emergency Electrical, Service Water, Drains/Waste/Vents, Condenser/Tower Water, Glycol Hot Water, Reheat Hot Water, USP Purified Water, Compressed Air, Vacuum, Nitrogen, Oxygen, Variable-Frequency Drives, UPS, Emergency Power Distribution, Chilled Water, Plant Steam, High Pressure Clean Steam, Autoclave and Glass/Parts Washer as part of a $250,000,000 dollar site expansion.
• Daily interface with construction contractors, sub-contractors, craft, engineering, stakeholders and facilities, P&ID system walk downs, review of turn over packages, installation and commissioning activities.

Project Engineer

Confidential, Richland, WA

Responsibilities:

• Project engineering work for 13 simultaneous projects concerning Double Shell Tank Farm and Waste Feed Delivery infrastructure and equipment to support the vitrification of transuranic waste at an active Defense Nuclear Facility:
• Technical Analysis and Project Definition for Double Shell Tank Farms(AY/AZ, AP, AN, AW & SY)
• Waste Transfer System
• Double Shell Tank Farms Corrective Maintenance
• Building 616 Expansion
• SY AP Exhauster Upgrade Specification
• Long Length Contaminated Equipment DOT 7A Type A Container (60’ x 5’ x5’)
• Cathodic Protection System Upgrades Double Shell Tank Farms
• Tank Farm Projects Project Management Support
• Developed technical documents, specifications, Engineering Change Notice ( Confidential ), statements of work, scopes of work, generated equipment requests, generator knowledge information, chain of custody, request for sample analysis forms and material requests.
• Reviewed engineering studies, drawings, bill of materials, parts lists, work packages, design documents, analyzed technical documents, and performed technical evaluations of vendor proposals, risk assessment studies and assisted in the preparation of material for review by the Defense Nuclear Facilities Safety Board (DNFSB).
• Liaison to area managers, field work supervisors, tank farm system engineers, field technicians, central engineering, design authority, planners, work package writers, project control, subject matter experts (SME), procurement, quality assurance, document control, and vendors.
• Co-chair of the Voluntary Protection Program (VPP for Base Operations/Tank Farm Projects (TFP) 800+ lives).
• Member Employee Accident Prevention Committee (EAPC), reviewed safety walk down reports.
• Member Problem Evaluation Resolution reports (PERs) Committee, interfaced with conduct of operation coaches, developed safety based initiatives and served on safety committees.
• Member VPP-Integrated Safety Management System (ISMS) and Presidents Accident Prevention Council (PAPC).

Validation Specialist

Confidential, PA and NC

Responsibilities:

• Wrote summary reports, standard operating/preventative maintenance procedures, performed GAP analysis, and developed spare parts programs.
• Provided value added engineering and facilities support.
• Understanding of Aseptic fill process for injectable product, Kaye validators, temperature control, Sub-zero freezers, clean rooms, gowning, air lock interlock systems, packaging, labeling equipment and lines.
• Functioned as a liaison between Engineering, Validation, QC, QA and Management to improve project work flow.
• Verified and updated instrument calibration certifications and ensured proper tagging for equipment.
• Walked down P&ID’s, commissioned equipment, wrote and executed protocols for; HVAC and BAS/BMS (Siemens Apogee), Clean Steam Generators (Steris), Reverse-Osmosis, De-ionized Water, Hot Water systems, Chilled Water, Micro/Ultra/Nano filtration, gas fired Steam Boilers, Bulk Nitrogen (Airgas), USP Purified Water, WFI, Fermentation Vessels, Portable Tanks, Transfer Tanks and lines, CIP/SIP skids, glassware and parts washers (Steris & HAMO), and Autoclaves.

Sr. Business Developer

Confidential, Raleigh, NC

Responsibilities:

• Facilitated Lean-Sigma meetings for clients.
• Trained for and executed Confidential events.
• Executed positive change through process mapping.
• Provided methodology development for de-bottlenecking production.
• Designed, implemented and instructed J.I.T. (Just-In-Time) manufacturing programs.
• Mentored managers and business owners using the Sandler Sales method.

President

Confidential, Pittsburgh, PA

Responsibilities:

• Served the following industries in a multi-national capacity: O&G refineries, chemical, petrochemical, nuclear, power, steel, metals, mining, pulp & paper, pharmaceutical, plastics, automotive, aerospace, glass, Confidential & Confidential, Confidential ’s, system integrators and government agencies.
• Executive level management, P&L responsibility, budget compliance business development, project engineering/management, field engineering, facilitated business/project coordination meetings, recruited, trained and mentored a staff of 9 employees, plus 10 contract workers.
• Managed, provided direction, guidance, compliance and expertise for the following activities in accordance with site procedures, quality standards, best engineering / manufacturing practices, national codes, safety and State/Federal regulations
• Engineering calculations, cost estimation and system design for heat/mass transfer process equipment such as heat exchangers, co-current and countercurrent extraction towers, reactor vessels, piping, HVAC, hydraulics and lubrication equipment
• Contract/supplier negotiation/award/terms/pricing, procurement, bid package proposal/preparation, vendor/contractor oversight, subcontract administration, vendor document review, item equivalency evaluations
• Team integration, departmental/client liaison, schedule, scope, project engineering/management, performance metrics, project execution plans, resource allocation and engineering change control
• Technical writing, development of specifications and standards from user requirements
• Consulting engineering services, design, planning, installation, field commissioning and start-up assistance
• Maintained process/system devices and components for heat and mass transfer, water and waste water treatment, zero discharge and environmental equipment
• Root cause failure analysis, process mapping, Lean, Six Sigma and process improvement activities
• Strong experience with the following systems; membrane and filtration, gaseous based mass transfer systems, steam generation, hydraulics, pneumatics and lubrication, hot oil, compressed air, pollution abatement, jacketed reactor vessels, open and closed loop water, aggressive system environments, clean steam and superheated / saturated steam, process systems, co-current and counter current stripping/ absorption towers, ultra-pure water, treatment/ waste water and filtration, piping, pumps, valves and components, tank farms, HVAC/Building Management/Building automation, motion control, material handling and instrument and controls.

Vice President

Confidential, Pittsburgh, PA

Responsibilities:

• Managed Hazardous, Residual, RCRA, CERCLA and TSCA waste consulting and engineering projects in conjunction with Confidential Stallard PhD, P. Confidential . and supervised 10 contract workers.
• Contracted with the 910th and 911th Air Wing of the Confidential for the remediation of Mercury laden Phosphor powder.
• Assisted clients with waste identification, characterization, documentation, storage, temporary storage, disposal, permitting, DOT regulations, compliance issues and forms as specified in 40 Confidential parts 260-265, 266-270 such as but not limited to Uniform Hazardous Waste Manifest, Hazardous Waste Report forms 8700-12, 8700-13, 8700-23, Site ID and Temporary storage forms.