Engineering Project Management

APPLICANT OVERVIEW

Accomplished, self-driven, high level of independent initiative, technical professional with 27+ years of experience and skills in executive level management, P&L responsibility, business unit operation, team leadership, project management/engineering, driving on time and under budget project completion, value engineering, strong customer facing skills, negotiation, construction management, validation, regulatory compliance, start-up, commissioning, preventative/corrective maintenance programs, government contracts and process improvement.

RELEVANT ENGINEERING AND INDUSTRIAL EXPERIENCE (Very detailed information available upon request.)

Project Manager / Sr. Validation Lead, Tolmar (Aseptic fill), Windsor, CO (Nov 2016-Present contract)

(~6-month contract) Provided Project Management and Lead Validation support to for Facilities, Utilities, Systems and Equipment (FUSE) on an $80,000,000 site expansion for Eligard a prostate cancer suppression drug.

Quality Assurance, Novo Nordisk (API/Aseptic fill, final product), West Lebanon, NH (May 2016-November 2016)

(~7-month contract) Provided Quality Assurance (QA) review and support of FUSE for the renovation of a life sustaining Hemophilia drug GMP manufacturing facility.

Approved and closed all quality based documents ahead of schedule. (1 to 3-day review turnaround time.)

Sr. Validation Engineer, GSK/Novartis (OTC facility), Lincoln NE (November 2015- May 2016)

(~7-month contract) Providing validation an dengineering support for a $1,000,000+ project to replace 220 controllers, servers, work stations, various network infrastructure, room specification /classification project, BMS room settings project to support GMP and non-GMP areas of an Over the Counter (OTC) remedy manufacturing facility.

Computer System Validation (CSV) for Siemens and Andover BMS.

Managed the on-time completion of a specification development, room classification, temperature, humidity and differential pressure project.

Project Manager / Site Representative, E&J Gallo Wines, Sunnyside WA (January 2015- November 2015)

(~11-month contract) Responsible for project and construction engineering management for a $12,500,000+ site expansion.

Completed several sub-projects on time and under budget through value engineering and vendor oversite.

Sr. Validation Engineer, Mallinckrodt Pharmaceuticals (API/Oxycodone Pill), Saint Louis, MO (November 2014- January 2015)

(~3-month contract) Validation engineering and FUSE IQ, PQ, OQ protocol authoring and execution.

Completed all protocols on time or ahead of schedule.

Project Manager / Site Representative, Syngenta (R&D/ production), Woodland CA (December 2012- June 2014)

(~18-month contract) Responsible for construction, engineering management, crews of over 65 workers, design and safety for an $11,000,000+ site expansion.

Managed Site Safety orientation and spot inspections to provide over 30,000 incident free man hours while delivering on time results.

Realized project cost savings of ~ $500,000 through value engineering, contractor management and cost controls.

Kept scope creep and overrun costs to under 6% the of project budget.

Delivered the project close to on time despite a 4 month delay due to weather, contractor and vendor issues.

Sr. Validation Consultant, Genzyme (Orphan Drugs), Boston MA (June 2012 – December 2012)

(~6-month contract) Project, validation, facilities engineering support, SOP, protocol authoring/execution and contractor liaison for a Consent Decree Remediation of QC Laboratory and FUSE as part of a $250,000,000-dollar site expansion.

Project Engineer, Washington River Protection Solutions, Hanford /Richland WA (April 2010 – October 2011)

(~18-month contract) Project engineering work for 13 simultaneous projects concerning Double Shell Tank Farm, Waste Feed Delivery infrastructure and equipment to support the vitrification of transuranic waste at a Defense Nuclear Facility.

Value engineered and negotiated cost savings of ~ $250,000.

Developed technical documents, specifications, Engineering Change Notice (ECN), statements of work, scopes of work, generated equipment requests, generator knowledge information, chain of custody, request for sample analysis forms and material requests. 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).

Validation Specialist, Day & Zimmermann & Concentric BioPharma, PA and NC (April 2006 – December 2009)

(~3 years contract work) Authored and executed FUSE Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) validation protocols based on user requirements to meet cGMP/FDA regulations in accordance with site procedures.

Wrote summary reports, standard operating/preventative maintenance procedures, performed GAP analysis, and developed spare parts inventory reduction programs with estimated savings of ~ $750,000 per year.

Provided value added engineering and facilities support.

Sr. Business Developer TBM Account, Strategic Sales Growth, Raleigh, NC (March 2002 -2004) (2 years)

Facilitated Lean-Sigma meetings for clients.

Trained for and executed Kaizen events.

Executed positive change through process mapping.

Mentored managers and business owners using the Sandler Sales method.

President, Hinkel and Associates, Inc., Pittsburgh PA (10 years)

Served and consulted to the following industries in a multi-national capacity: pharmaceutical, O&G refineries, chemical, petrochemical, nuclear, power, steel, metals, mining, pulp & paper, plastics, automotive, aerospace, glass, E&C, OEM’s, system integrators and government agencies (DOE, DOD etc.).

Executive level engineering management, achieved $6,000,000 in sales revenue with a net profit of 30% margin, P&L responsibility, budget compliance, business development, project engineering/management, regulatory, quality, code and standard compliance.

Recruited, trained and mentored a staff of 9 employees, plus 10 contract workers.

Saved customers millions of dollars through alternative engineering which improved upon their base designs.

Consultative engineering for equipment design, process improvement, heat and mass transfer, process equipment, operations, R&D projects, facilities, spare parts programs, maintenance, air pollution abatement and water/waste water treatment.

Vice President, American Waste Management, Inc., Pittsburgh, PA (4+ years concurrent with Hinkel)

Managed Hazardous, Residual, RCRA, CERCLA and TSCA waste consulting and engineering projects $250,000+ in conjunction with Dr. Michael Stallard PhD, P.E. and supervised 10 contract workers.

Assisted clients with waste identification, characterization, documentation, storage, temporary storage, disposal, permitting, DOT regulations, compliance issues and forms as specified in 40 CFR 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.

EDUCATION University of Pittsburgh, Mechanical Engineering and Business Administration

(Special Fields of Administration and Technology 1987)

Computer skills: Microsoft Office, MS Project, Windows, Passport, MySQL, DCMS, CHAMPS, AutoCAD, SharePoint, Smart Solve, Autodesk Design Review, MATHCAD, Adobe Acrobat, Corel Draw, Newforma, PaintShopPro and Bluebeam.

Below is a small example of the work I have done. Please reach out to the writer for additional details.

Project Management/Engineering, Construction Management and Consulting Services serving light to heavy industries in a multi-national capacity up to $500,000,000 in project cost.

Responsible for project, engineering and construction management of up to 65 workers, managed Site Safety while delivering on time results, capital request, budget preparation, statements of work, scopes of work, 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, assisted in the preparation of material for review by the Defense Nuclear Facilities Safety Board (DNFSB).

Supervised geotechnical drilling, piping, civil road work, geotechnical, surveying, utility location, process equipment installation, auger renovations, hoist repairs, electrical upgrades, concrete work, tank design and installation, lifts by large cranes, 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.

Provided methodology development for de-bottlenecking production. Designed, implemented and instructed J.I.T. (Just-In-Time) manufacturing programs. Root cause failure analysis, process mapping, Lean, Six Sigma and process improvement activities.

Consulting engineering services, design, planning, installation, field commissioning and start-up assistance. Managed, provided direction, guidance, compliance and expertise in accordance with site procedures, quality standards, best engineering / manufacturing practices, national codes, safety and State/Federal regulations (i.e. NFPA, NEC, ASME, ANSI, ISO, API, NACE, IEEE, FDA, EPA, etc.).

Pharmaceutical Project Management, Quality Assurance and Validation support for Facilities, Utilities, Systems and Equipment (FUSE) for projects up to $300,000,000 in cost to meet GMP/cGMP/FDA/EU regulations and practices.

Daily interface with C level executives, engineering, project management, stakeholders, facilities, construction, contractors, sub-contractors and craft. Provided value added engineering and facilities support. Liaison between departments to improve project work flow. Facility types include; Aseptic fill, Active Pharmaceutical Ingredients (API), Over the Counter (OTC), Orphan Drugs and Contract Manufactures.

Authoring, approval, review and execution of documents such as, but not limited to the following; Installation, Operational, Performance Qualifications Protocols (IQ, OQ, PQ), Validation Summary Reports, Deviations, User Requirement Specifications (URS), Functional Specifications (FS), Software Design Specifications (SDS), Hardware Design Specifications (FDS), Design Qualification (DQ), Validation Plans(VP), Validation Master Plans (VMP), Change Control, Root Cause Failure Analysis (RCFA), Standard Operating Procedures (SOP’s), Change Control (CC), Corrective and Preventive Action (CAPA), Failure Mode Effects Analysis (FMEA), Preventative Maintenance Procedures (PMP), Spare Parts Programs (SPP), Inventory Reduction Programs (IRP), GAP analysis, Computer System Validation(CSV), Engineering Turn Over Packages (ETOP’s), Smoke Studies, Installation and Commissioning.

FUSE work such as, but not limited to the following; Clean Rooms, Cold Rooms/Refrigeration, Freezers from 0 to -80 0C, Building Utilities, Water for Injection (WFI), USP Purified Water, Reverse-Osmosis (RO), De-ionized Water (DI), Plant Water, Service Water, Hot Glycol Water, Cold Glycol Water, Reheat Hot Water, Chilled Water, Micro/Ultra/Nano filtration, Compressed Air, Vacuum, Nitrogen, Bulk Nitrogen (Airgas), Oxygen, Plant Steam, High Pressure Clean Steam/Generator (Steris), Clean In Place (CIP), Steam In Place (SIP) Electrical Power Distribution, Emergency Power Distribution, Emergency Power Generators, Uninterruptable Power Supply (UPS), Drains/Waste/Vents, Condenser/Tower Water (open and closed loop), Variable-Frequency Drives, Tanks (holding, portable, transfer, process and mixing / blending, reslurry), Fermentation Vessels, Environmental Monitoring, Viral Filtration, Chromatography Columns, Fume Hoods, Laminar Flow Hoods, Bio Safety Cabinets, Autoclaves (Steris, Belimed) Depyrogenation Oven (Belimed), Optima De-nester, Inspection Tables, Labelers, pumps, IMA Lyomax Lyophilizer, Optima syringe filling line, IMA ALUS, Temperature Mapping, Lethality, Bioburden and Endotoxin Studies, Network Controllers, Servers, Work Stations and various Network Infrastructure, HVAC and BAS/BMS (Siemens Apogee, Johnson Controls Metasys and Andover Continuum), Air Handling Units (AHU), Variable Air Volume (VAV), Emergency Exhaust System, Bag Filters, Oxycodone Belt Filter Press, Kaye Validators, Air Lock Interlock Systems, Packaging, Labeling lines, Instrument Calibration Certifications, Transfer Lines, various skid mounted systems, Pumps, Glassware and Parts Washers (Steris & HAMO).

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