Engineer Manager
Resume:
JASON HEBERLE, CTP
*** *** ** ***.* HOBOKEN, NJ *7030
************@*****.***
WORK EXPERIENCE:
APLICARE –Meriden, CT ( 3/18- Present)
PHARMACEUTICAL PACKAGING ENGINEER (CONTRACT)
- Create and run FAT, SAT, IQ, OQ and PQ for Packaging Equipment
- Design and validation of packaging systems
PCI –Philadelphia, PA ( 9/17- 12/17)
EQUIPMENT PROCESS ENGINEER (CONTRACT)
- 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
REGENERON –Albany, NY (4/17-7/17)
COLD CHAIN VALIDATION ENGINEER (CONTRACT)
- 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
JOHNSON AND JOHNSON, DEPUY SYNTHES –WEST CHESTER, PA (7/15-3/17)
PACKAGING ENGINEER (CONTRACT)
- 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
INTEGRA LIFE SCIENCES-PLAINSBORO, NJ (11/13-7/15)
SENIOR PACKAGING ENGINEER (CONTRACT)
- 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
ASTRA ZENECA-BENSALEM, PA (7/13-10/13)
VALIDATION ENGINEER (CONTRACT)
- Process and equipment validation to ISO and cGMP for FDA regulated pharmaceutical manufacturer
- 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
TCP/CRYOPAK - EDISON, NJ (12-08 TO 4/13)
COLD CHAIN PACKAGING ENGINEER/ LAB MANAGER
- 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
- Lead lab for ISO and ISTA certifications and development of new FDA compliant procedures
STANLEY-BOSTITCH- PROVIDENCE, R.I (12/07- 3/08)
PACKAGING ENGINEER (CONTRACT)
- Responsible for implementation of new business packaging developments for fasteners and nail tools
- Worked with Asian and US based material and packaging manufacturers
- Set up pallet, truck and container loads using CAPE Pack for worldwide distribution
THE GILLETTE COMPANY- BOSTON, MA (10/05 -12/06)
SENIOR PACKAGING ENGINEER
- Lead Engineer for Braun and Oral-B Power brands responsible for development and manufacturing
of 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
of 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
HASBRO TOY COMPANY- PROVIDENCE, RI (5/03 -11/04)
PACKAGING ENGINEER (CONTRACT)
- Developed and designed structural packaging for retail distribution in corrugated, folding cartons,
blisters 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
HARLEY DAVIDSON MOTORCYCLE COMPANY- YORK, PA (12/01-7/02)
PACKAGING ENGINEER INTERN
- 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
UNITED STATES ARMY - (10/91- 03/99)
CORP OF ENGINEERS, ACTIVE DUTY COMBAT ENGINEER
- Designed and constructed bridges, roadways and structures
- Team leader for seven man engineer squad responsible for training and safety
- Trained US and Foreign soldiers in demolition and vehicle operations
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
ECT, Mullen, Bubble, Burst, Peel, Vacuum
Packaging Equipment: Cartoners, Bottlers Cappers, Conveyors, PLCs, Induction Sealers, Blister Sealers, Form filler Sealers, Refrigeration Units
EDUCATION:
Rochester Institute of Technology
Packaging Science
GPA 3.3
ASSOCIATIONS:
International Organization of Packaging Professionals (IoPP)
International Safe Transit Association (ISTA)
Member of ISTA Thermal Executive Council
American Foreign Legion
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