Shakopee, Minnesota, United States
Project Manager with 7+ years of experience leading capital and operational projects within GMP manufacturing environments. I specialize in executing complex work in active facilities where schedule, compliance, and production risk must be carefully balanced. My experience includes cleanroom construction, utility infrastructure (WFI, Pure Steam, HVAC, nitrogen, compressed air), and equipment installation and qualification. I’ve led multi-week shutdowns and full return-to-service planning in high-stakes manufacturing environments. I’m known for driving execution under pressure, coordinating cross-functional teams, and making decisions with incomplete information to keep projects moving forward. Currently focused on capital project leadership roles within biotech, medical device, or advanced manufacturing environments.
* Own end-to-end delivery of a portfolio of capital and operational facility projects within active regulated manufacturing operations * Led cross-functional execution of aseptic fill room expansion including cleanroom construction, utility integration (WFI, nitrogen, compressed air), equipment installation, and commissioning in an active GMP facility * Lead infrastructure upgrades, capital equipment installation, and operational readiness initiatives across manufacturing and quality organizations * Drive commissioning, acceptance testing, documentation turnover, and system readiness for GMP operations * Serve as site project lead for complex infrastructure and capital equipment upgrades impacting manufacturing operations * Present project status, risks, and mitigation strategies to site leadership and executive stakeholders
Managed capital facility projects supporting site expansion and infrastructure upgrades * Coordinated design, installation, testing, and system handover within active manufacturing environment * Served as facilities SME during FDA and customer audits * Developed SOPs, preventive maintenance plans, and operating procedures for facility systems * Provided technical support for HVAC, chillers, boilers, pumps, and filtration systems
Supported operation and reliability of facility and utility systems in regulated manufacturing * Coordinated maintenance, troubleshooting, and repair of HVAC, boilers, chillers, and building systems * Assisted with execution of capital and maintenance projects within GMP environment * Participated in audits, investigations, and continuous improvement initiatives
- Conduct field walks to certify reliability and safety of equipment in accordance with NRC regulations. - Designed, developed, and enhanced program layouts to improve short and long-term plant efficiency. - Managed engineering changes from start to finish while collaborating with multiple departments to ensure safety and quality changes. - Revised calculations for field tests done to validate engineering changes to plant equipment. - Worked in a team to solve complicated problems within the plant programs that lead to the improvement of systems.
- Presented multiple design recommendations to project engineers - Exhibited creative problem solving for complex technologies to save time during field work data collection. - Developed cost estimates with Microsoft Excel and organize projects for easier analysis. - Planned and managed time effectively while working independently, with minimal supervision.
- Considered heating and cooling systems used in each house to project the efficiency of each home. - Developed collaborative skills when working in a team environment. - Use of Sketch-Up and Microsoft Excel for energy models of each house.