TECHNICAL SKILLS:

Software: Microsoft Office: Word, Excel, Power Point, Access, Visio, Project, Minitab

Adobe: InDesignCS, PhotoShopCS, Illustrator CS, QuarkXpress

CAD: AutoCAD, Solid Works, ImpactCAD, ArtiosCAD, NX

Logistics: Cape PACK, TOPS

CAM: Kongsburg, Misomex and DataTech

PLM: SAP, Windchill, Agile

ERP: JDE, AS 400

Temperature Validation Systems: Kaye KL and Kaye 2000, ATP Thermprofile, Madgetech

Packaging Testing Equipment: Drop, Incline, Compression, Rotary and Dynamic Vibration Lansmont Certified

Packaging Equipment: Cartoners, Bottlers Cappers, Conveyors, PLCs, Induction Sealers, Blister Sealers, Form filler Sealers, Refrigeration Units

WORK EXPERIENCE:

Confidential - Philadelphia, PA

EQUIPMENT PROCESS ENGINEER (CONTRACT)

Responsibilities:

• Set up and validation of packaging equipment Develop process to set up high speed fully automated packaging lines within clean rooms Selection of equipment specific to individual product lines

Confidential - Albany, NY

COLD CHAIN VALIDATION ENGINEER (CONTRACT)

Responsibilities:

• Validation of cold chain shipping and procedures, mapping of refrigerated equipment Development of new procedures for cold chain logistics related to biological pharmaceuticals Cost savings and process developments related to global shipping

Confidential - WEST CHESTER, PA

PACKAGING ENGINEER (CONTRACT)

Responsibilities:

• Responsible for supporting European operations for US manufactured Class I and II medical devices Development of specifications and databases for packaging of medical devices between US and Europe Verification and selection of packaging materials for bio-compatibility throughout product life cycle Remediation of TUV and ISO audit deficiencies related to packaging distribution and shelf life documentation

Confidential -PLAINSBORO, NJ

SENIOR PACKAGING ENGINEER (CONTRACT)

Responsibilities:

• Responsible for the development and execution of Engineering Studies, FMEA Risk Assessments, Design
• Qualifications, Commissioning, IOQ and PQ documents for new equipment for the manufacturing and packaging of collagen based skin products in a FDA regulated manufacturing facility
• Engineer manager for equipment procurement, installation and validation into ISO5 (Class 1000) clean room for new product launch Design and purchase of tooling, fixtures and material movement equipment and developing process flows for personnel and material movement for raw material and finished goods Statistical data analysis for packaging material test data and setting up Process Capability Values (Cp) for production

Confidential -BENSALEM, PA

VALIDATION ENGINEER (CONTRACT)

Responsibilities:

• Process and equipment validation to ISO and cGMP for FDA regulated pharmaceutical manufacturer Document validations per GDP for regulatory agency submission Specialized in sea, ground and air cold chain distribution validation of equipment, temperature lanes and processes Mapping of chambers and trucks using Kaye validation systems Investigation and root cause analysis for process complaints and non-conformances from internal and external sources

Confidential - EDISON, NJ

COLD CHAIN PACKAGING ENGINEER/ LAB MANAGER

Responsibilities:

• Management of a Thermal Performance Testing Lab with multiple high performance chambers and conditioning chambers supporting cold chain development and distribution worldwide Develop and test new pharma packaging systems using EPS, PIR, PUR, HDPE, corrugate and phase materials Test and validate thermal packaging for temperature, shock and vibration to ISTA and ASTM standards for
• FDA submission and approval
• Temperature mapping of distribution lanes and equipment using wired and wireless sytems of corporate personnel at nationwide locations on thermal performance testing Lead lab for ISO and ISTA s and development of new FDA compliant procedures

Confidential - PROVIDENCE, R.I

PACKAGING ENGINEER (CONTRACT)

Responsibilities:

• Responsible for implementation of new business packaging developments for fasteners and nail tools Worked with Asian and US based material and packaging manufacturers Created new pallets and 3D CAD drawings for increased load efficiency and cost savings Set up pallet, truck and container loads using CAPE Pack for worldwide distribution

Confidential - BOSTON, MA

SENIOR PACKAGING ENGINEER

Responsibilities:

• Lead Engineer for Braun and Oral-B Power brands responsible for development and manufacturing f promotional packaging and Point of Purchase (POP) Created custom and Pack to Order (PTO) floor stands, powerwings and pallets for retail and club markets Lead engineer for Gillette Blades and Razors special packs including the conception and manufacturing f blister packs, RF sealed thermoforms, shrink bands, gift packs and foil cartons Responsible for tooling approval, manufacturing cost approval (materials, labor and overhead), issuance of purchase orders and distribution of a combined annual budget of 50 million dollars

Confidential - PROVIDENCE, RI

PACKAGING ENGINEER (CONTRACT)

Responsibilities:

• Developed and designed structural packaging for retail distribution in corrugated, folding cartonsblisters and thermoforms using ImpactCAD and SolidWorks CAD programs Created tooling specifications and 3D drawings Designed packaging for product lines including GI JOE, Mr. Potato Head, Playskool and Tonka

Confidential - YORK, PA

PACKAGING ENGINEER INTERN

Responsibilities:

• Managed daily packaging operations for a large automobile plant Implemented and managed new supply loops in a multi-million dollar returnable container loop Designed packaging and packaging cushioning in CAD using plastic corrugated (PCORR), cross linked polyethylene (XLPE), molded foam trays and metal racks

Confidential

CORP OF ENGINEERS, ACTIVE DUTY COMBAT ENGINEER

Responsibilities:

• Designed and constructed bridges, roadways and structures Team leader for seven man engineer squad responsible for and safety Trained US and Foreign soldiers in demolition and vehicle operations