Innovative Engineer known for high productivity and efficient task completion. Specialize in project management, process improvement, and technical troubleshooting. Possess strong problem-solving, critical thinking, and teamwork skills, enabling successful collaboration and innovative solutions. Excel in fast-paced environments requiring attention to detail and adherence to deadlines.
Overview
35
35
years of professional experience
1
1
Certification
Work History
CPhT, PROCESS ENGINEER
VETERINARY PHARMACEUTICAL SOLUTIONS
SAINT PETER, USA
02.2002 - Current
Process Engineer, CPhT, CSPT
Ensured precision and safety in the preparation of intravenous admixtures using sterile techniques in laminar flow hoods.
Developed and revised SOPs to align with USP, FDA, NABP, and cGMP guidelines.
Coordinated with FDA, NABP, and MN Board of Pharmacy during inspections, addressing operational issues with a focus on mechanical and process compliance.
Designed, implemented, controlled, and optimized the product's compounding phase from start to finish.
Collaborated with stakeholders to establish key performance indicators aligned with strategic objectives while ensuring regulatory compliance.
2024 Current Projects:
8,700 sq. ft. pharmaceutical facility expansion to include new office space, new R&D lab, new cleanroom installation, additional production bays, and additional warehouse space. The project kicked off in December 2023, and it is scheduled for completion in spring 2025.
β-Lactam Powder handling process resulted in an increase of 13% (2.2M savings on active pharmaceuticals loss), a 99% reduction in aerosolized powders, a 0 lift process, and floor space recovery of 1,800 sq ft.
Collaborated with KAMP Automation to develop a custom automation system for a proprietary sterile injectable product. This project will increase efficiency and capacity to more than 3X, while eliminating operator-introduced risk of contamination of the finished product (530K). Reduction of labor by 50%, and 100% elimination of puncture and exposure injuries. All performance qualifications were completed in September 2024, and the system was placed online on October 2, 2024.
2023 Completed Projects:
Designed large-bore spikes for our sterile cleanroom process. This project was due to a market shortage of sterile I.V. spikes. This resulted in consumable savings of $27,000 annually. Redesign (late 2023) of spikes for the sterile automation system.
Led the MW Watermark filter press project, achieving a 17% recovery improvement and an 87% efficiency boost, resulting in $300,000 in last quarter revenue. Exceeded the 2024 sales forecast of 3.25 million in the product's first year post-launch.
R&D Lab Mass Spec instrument purchase (420K). This will allow us full, real-time quantitative analysis of existing and developing products.
Projects completed in 2022 include full buildout of R&D Laboratory from a compounding bay(140k), Installation of large capacity autoclave (102k), Installation of site-wide compressed air system (68k) and 3PL offsite warehouse storage
Project manager and principal SME for VetRx (VPS) relocation in 2008. Design/build of new 10,000 sq ft facility with ISG Architects and Vos Construction (1.5M)
R.O. TECHNICIAN / SITE LOGISTICS COORDINATOR
FILMTEC - DOW CHEMICAL COMPANY
EDINA, USA
01.1990 - 02.2002
Line technician involved with building RO elements, which included manual and automation rolling systems (AMEC), trimming, fiberglass rolling, chamfering, testing and packaging
Operated RO test equipment to ensure finished goods meet specifications
Member of the Emergency Response team
CPR and EMR Certified through Red Cross(no longer current)
Education
Engineering Design and Machining - Pro E and Solidworks focus
Study Start Up Associate II at Harvest Integrated Research Organization (HiRO)- previously known as Pharmaceutical Solutions Pty LtdStudy Start Up Associate II at Harvest Integrated Research Organization (HiRO)- previously known as Pharmaceutical Solutions Pty Ltd