Capable and interested in working within a package engineering team designing, controlling, changing, and/or sustaining all or parts of the products’ packaging system. My strengths would help organize and implement any packaging related projects in an effective and efficient manner. Familiar with cGMPs and have experience working in an FDA regulated environment.
Senior Packaging Engineer
Custom Building Products
April 2013 - January 2014
• Hired in as first and only packaging engineer on staff into R&D group.
• Assisted with packaging modifications to tertiary packaging for product launch to ensure oddly shaped product would arrive to customer in acceptable condition.
• Managed implementation of new carton design in response to packaging change - from manual process to automated equipment.
• Collected and organized packaging information (weight, dimensions, and shelf life) and entered into ERP system for engineering and warehouse needs.
Packaging Engineer II to Senior (APD Team)
St. Jude Medical, CAT Division
March 2011 - April 2013
• Performed remediation of all packaging department Manufacturing Instructions
• Executed package performance testing for all products utilizing package configuration matrix to minimize testing variables.
• Experience using Windchill (online documentation control system)
• Designed shipping container for new package design
• Member of team to remediate IQs, OQs, PQs
• Managed 3-month summer intern who successfully completed an Mfg Instruction remediation, three testing protocols, and designed a new more efficient palletized shipper sterilization load.
• Qualified a new package design (from coiled to straight package) for catheter family.
• Worked with SJM EtO sterilization expert during packaging qualifications. Acquired knowledge and experience regarding the balance of sterilization parameters and their effect on polymers.
• Assisted IT with troubleshooting manufacturing label issues. Learned how to navigate and work with Label Matrix and internal Labeling Database software.
• Organized Accelerated and Real Time Aging tests for products to maintain compliance with ISO 11607.
Manufacturing Engineer II (Packaging Specialist)
Bio-Rad Laboratories, Inc.
April 2007 - March 2011
• Functioned as sole Package Engineer within Manufacturing Engineering group.
• Gained experience with cold chain methodologies
• Planned, organized, and implemented a shipping qualification program into shipping department (for pallet loads and single parcel shipments)
• Created, updated, and organized packaging component specifications (labels, primary packaging, secondary packaging, tertiary packaging)
• Planned, executed, and documented component qualifications/acceptance tests in order to qualify secondary vendors
• Managed secondary package thermoform line (Tiromat PowerPak) rebuild project. Led team to successfully complete project within budget and on time.
• Owned and completed Non-Conformance Reports, corrective Actions, customer complaint investigations, and Audit responses (Internal, LNE, TUV, FDA audits)
• Member of team to establish complex 2D Data Matrix barcode label design necessary for new product initiative.
Packaging Engineer and Supplier Quality Engineer
May 2004 - March 2007
Supplier Quality Engineer
• Member of quality team to perform audits at vendor sites (Visited suppliers for: package inserts, glass tubing vials, corrugate containers, folding cartons, labels)
• Tracked vendor quality by monitoring supplier Non conformances, and component issues
• Member of the OCD/J&J recruiting team. Visited Universities to recruit new-hires/college grads
Packaging Engineer I to II
• Executed container-closure integrity qualifications
• Owned Packaging Change Controls (Authored, represented change in front of Change Control Board, and implemented change)
• Successfully completed package changes fulfilling FDA requirements and meeting strict deadlines.
• Worked closely with the graphics department to ensure product labeling met current marketing and regulatory needs.
• Gained working knowledge of Good Manufacturing Practices and Good Documentation Practices
• Completed component qualifications including production line tests within manufacturing
Qualifications & Certifications
B.S., Packaging Science
Michigan State University