Ivaylo Valirov

• Plant process equipment maintenance and compliance
• Project management of equipment and plant upgrades
• Generation and execution of change controls within a GMP environment
• In-depth investigation analysis using practical problem solving techniques like 5 Whys and Ishikawa diagrams to determine deviation root cause
• CAPA generation and implementation to improve equipment reliability and eliminate process quality issues
• Generation of equipment and process SOPs and batch records
• Manufacturing asset master data maintenance in CMMS and ERP
• Calibration and maintenance vendor management
• Hands on troubleshooting, repair, and maintenance of process equipment
• Engineering documentation: URS, PFD, P&ID, IOQ, PQ protocols/reports
• Statistical process control and data analysis
• Contractor management to design, install, and commision electrical, mechanical and piping system

B.S. Bioengneering & Materials Science and Engineering

2009 - 2013

University of California, Berkeley, Berkeley, CA

Focused on using general engineering principles and principe.

Sr. Process Engineer

2022 - Present

Eat Just (GOOD Meat) - Alameda, CA

Pilot Plant Process Engineer for novel cultured meat facility.

• Startup of a new state of the art facility to develop and scale up cultured meat production.

Manufacturing Process Engineer

2019 - 2022

Codexis - Redwood City, CA

System owner for all Pilot Plant upstream and downstream bioprocess equipment.

• Increased production capacity from 34% to 100% for 15 L E. coli bioreactor units
• Project management and technical lead for a $3 million plant equipment upgrade project to replace obsolete and unreliable equipment including bioreactors, centrifuges, fume hoods and lyophilizers
• Tech transfer of processes from development into Pilot Plant 15 L bioreactors and scale up to 650 L bioreactors
• Achieve 100% on time execution of preventive maintenance and calibration service through CMMS implementation

Manufacturing Engineer

2016 - 2019

AstraZeneca (Pearl Therapeutics) - Redwood City, CA

System and process owner for spray drying and jet milling equipment.

• Increased batch success rate from 88% to 97% YoY through increasing equipment reliability, documentation simplification and robust training
• Led an effort to reduce human error deviations by 93% by qualifying a new automated production line and implementing a new training program
• Reduced facility product changeover from 3 weeks to 1 week through parallel scheduling and elimination of non-value added steps
• Reduced manual batch record entry by 50% through the implementation of batch automation reporting and documentation improvements

Process Analytical Technology Engineer

2013 - 2016

Bayer - Berkeley, CA

Project Manager and technical lead for analytical equipment upgrade projects.

• Planned and executed analytical process equipment upgrade CAPEX projects up to $1 million in value within 5% of budget
• Led a sitewide reliability improvement project to replace over 100 obsolete analytical instruments
• Trained over 300 production operators and maintenance technicians on proper operation of cell counters, pH, DO, metabolite analyzers