Gerry Bonn

EMPLOYMENT

Process Engineer 2022 - 2024 Sysmex Reagents America, Inc. Mundelein, IL

●      Managed project for OEE Production Dashboard.

●      Managed project to install three new Westrock Meta case formers that will be installed in production.  This project is projected to save the plant > $1.0 M annually in corrugate cost.

●      Assisted with installation, characterization, documentation, and validation of new Line G bottle filling system.

●      Currently managing Purified Water conservation project in an effort to conserve water and reduce operational costs.

●      Currently managing project to remove and replace EOL Allen-Bradley control panels and modules on all packaging lines.

●      Drafted new User Requirements Specification (URS) template and related SOP to assist Sysmex with planning and designing new equipment.

Sr. Process Engineer 2018 – 2020 PharMEDium Services LLC Lake Forest, IL

• Project engineer on automated bag filling and labeling machine, utilizing Fanuc robotics and  Rockwell Programmable Logic Controllers (PLCs).

• Drafted Site Validation Master Plan (SVMP) for Dayton, NJ facility.

• Project Manager for Cleveland, MS Facility and Equipment Decommissioning Project.

Process Engineer – Consultant 2015 – 2017 Merz North America Sturtevant, WI

• Project lead to design, install, and validate air classifier system to be used by particle  manufacturing operation to improve throughput volume and quality.

• Drafted Process Failure Mode Effects Analysis (PFMEA) for air classifier and V-Blender.

• Drafted Design Specification, Manufacturing Standard Operating Procedures (SOPs) for air  classifier and v-blender.

• Trained manufacturing personnel on all SOPs relating to air classifier and new processes.

• Project lead for v-blender system to be used by particle manufacturing to increase product  throughput.

• Lead, plan, design, and coordinate equipment design modifications with external vendors and  highly matrixed internal cross-functional teams.

• Lead project to develop, plan, design, and validate alternative centrifuge bag for dewatering  calcium hydroxyapatite (CaHA).

• Draft and execute validation (IQ,OQ,and PQ) and engineering studies as required to maintain the  highest quality and regulatory compliance of all new/modified manufacturing equipment.

Technical Support Engineer 2013 – 2014 Leica Biosystems Richmond, IL

• Lead equipment projects for the manufacture of pathology consumable products.

• Resident expert for equipment troubleshooting and employee training.

• Validation and verification (IQ, OQ, PQ) of existing FDA regulated equipment/process changes. • Lead, plan, design, and oversee new product and equipment installation and integration. • Work with external vendors/contractors to obtain quotes on equipment or services.

• Create/revise work instructions/standard operating procedures. Train employees on the proper  use of those SOPs.

• Key team member on kaizen continuous improvement lean efforts.

Lead Service Engineer – Magnetic Resonance 2011 – 2012 GE Healthcare Waukesha, WI

• Responsible for all service-related issues pertaining to the global magnetic resonance system  installed base.

• Lead service methods documentation revisions/issues.

• Created and executed software verifications (IQ, OQ, PQ) for multiple software platforms.

• Responsible for engineering changes and releasing new system parts for the global installed  base.

• Experience working on cross functional teams to introduce new hardware and software, as well  as address CAPA investigations and concern reports.

• Created and verified numerous field modification instructions to address global field issues.

Supply Chain Manufacturing Program Manager 2007 – 2011 GE Healthcare Barrington, IL

• Responsible for all Design Transfer of new/revised computer hardware and software to manufacturing  as a result of either New Product Introduction or End-Of-Life, as well as the Phase In/Phase Out  process as part of GE's Global Supply Chain.

• Worked within cross functional core teams to understand and co-ordinate project deliverables and  timelines.

• Worked closely with manufacturing to co-ordinate and perform hardware and software verifications  prior to manufacturing release.

• Wrote/revised numerous manufacturing work instructions. Conducted training for manufacturing  teams, both in house and remotely to international sites.

• Extensive experience in constructing Bills of Materials for both hardware and software product  offerings.

• Lead new software and hardware product roll out from engineering to manufacturing.

CONSULTANT 2004 - 2007 Automated Systems Lake Bluff, IL

• Sales of consulting services to pharmaceutical/healthcare/medical device clients.

• Advised pharmaceutical/healthcare/medical device clients on regulatory compliance with Federal and  International Agencies, validation, equipment and troubleshooting issues.

• Wrote and executed validation protocols (IQ, OQ, PQ) for pharmaceutical equipment, processes,  facilities, and utilities.

PROJECT ENGINEER 2001 - 2004 Abbott Laboratories North Chicago, IL

• Managed capital projects for equipment, utilities, and facilities from concept to completion.

• Lead project to eliminate nitrogen gas from solution transfer room. Project was completed ahead of  schedule and $200K under budget. The project was budgeted for $250K. After careful analysis and  discussions with manufacturing, I created a design to pipe the nitrogen gas out of the room through  the ceiling and out the wall of the building. It was originally thought that this project would require  installing new HVAC units on the roof of the building.

• Lead project to decommission third party manufacturing and packaging line and shipped all  equipment to third party customer in Utah. .

• Wrote validation protocols (IQ, OQ, PQ) for pharmaceutical equipment, utilities, and facilities. • Monitored daily operation of water for injection (WFI) systems.

• Analyzed and troubleshot manufacturing process / equipment problems.

ENGINEERING/MAINTENANCE MANAGER 2000 - 2001 Abbott Laboratories North Chicago, IL

• Managed approximately fifty maintenance/engineering personnel and equipment for production  operation for all three shifts. Troubleshot equipment issues. Installed and validated new production  and packaging equipment. Mentor and develop employees. Write and administer performance  reviews.

• P & L responsibility for $5M department budget.

• Analyzed and re-validated fentanyl citrate production and packaging line to improve throughput.  Oversaw and performed an engineering study to eliminate a packaging bottleneck. This effort  reduced processing batch time 50% from twelve hours to six hours.

ADDITIONAL EXPERIENCE

PROCESS ENGINEER

Abbott Laboratories North Chicago, IL

• Troubleshoot and lead changes to flexible container fabrication equipment.

• Write validation protocols (IQ, OQ, PQ) for pharmaceutical equipment, facility, utility, and process  changes.

• Played a major role in decommissioning plant and equipment and moving production to other  manufacturing sites to create a cost savings to the plant of $5MM annually.

MAINTENANCE FOREMAN

Abbott Laboratories North Chicago, IL

• Managed maintenance personnel for production and plastic extrusion equipment set-up for all three  shifts. Wrote performance reviews. Coached employees. Performed hiring and termination. Wrote  and executed validation protocols (IQ, OQ, PQ) for pharmaceutical manufacturing equipment,  facilities, and utilities. Lead employee safety meetings.

• Managed maintenance budget. Reduced annual maintenance budget by $65K by eliminating  overstock and parts no longer required and by closely monitoring expenditures.

ENGINEER TECHNICIAN

Abbott Laboratories North Chicago, IL

• Supported plant projects with engineering/technical expertise.

• Worked on development teams for new technologies and processes.

• Fabricated new prototype equipment for heat sealing an administration port into a flexible plastic  intravenous container. The production equipment is now in service at Abbott’s Austin, TX plant.

• Journeyman Mold Maker (plastic injection, plastic extrusion, blow mold, form/fill/seal, aluminum and  zinc).

• Fabricated prototypes, jigs, fixtures, and plastic injection molds.

EDUCATION / SKILLS

MBA

Keller Graduate School of Management Oakbrook Terrace, IL

B.S. BIOLOGY

University of Wisconsin - Parkside Kenosha, Wisconsin

Master Black Belt Lean Six Sigma Certification Program Villanova, PA Villanova University