Work

Process &ManufacturingEngineer

Experience in process development, pilot operations, scale-up, manufacturing engineering, equipment, and process data systems across cell culture, fermentation, and biopharmaceutical production.

Portrait of Ivaylo Valirov
Fremont, CaliforniaPharmaceutical Process Engineer
Flask → 3 kLbioreactor scale-up experience
95%less time generating routine process graphs
60%production increase using existing equipment
93%reduction in campaign deviations

Focus areas

What I work on.

01

Process & manufacturing engineering

  • Process optimization and troubleshooting
  • Production planning and operations support
  • Equipment reliability and lifecycle management
  • GMP documentation, validation, and tech transfer
02

Process development & pilot work

  • Experimental design and parameter screening
  • kLa, P/V, tip speed, and scale-up studies
  • Bioreactor scale-up from flask to 3 kL
  • Fermentation transfer from 15 L pilot to 650 L
03

Systems, Excel & dashboards

  • Excel process-performance dashboards
  • Ignition SCADA and plant historian implementation
  • Statistical process control and data visualization
  • Power BI, Python, JMP, SQL, and automation data
04

Lean manufacturing

  • Value-stream mapping, 5S, kaizen, and Kanban
  • Standard work and visual management
  • Root-cause analysis, 5 Whys, and Ishikawa
  • Waste, changeover, downtime, and cost reduction

Experience

Role history.

2024–Present

Staff Engineer

Vaxcyte · San Carlos, CA

  • Startup of a new fermentation pilot facility.
  • USP MSAT representative for a CDMO clinical manufacturing facility.
  • Data integration and dashboarding for pilot and manufacturing process data.
2022–2024

Sr. Process Engineer

GOOD Meat (Eat Just) · Alameda, CA

  • Engineering lead for pilot-scale stainless-steel and single-use cell culture equipment.
  • Led scaling studies and defined process parameters through 3,500 L.
  • Implemented an Ignition SCADA/historian system and an Excel process dashboard.
  • Reduced routine graphing time by 95% and operational cost by more than 50%.
2019–2022

Manufacturing Process Engineer

Codexis · Redwood City, CA

  • Transferred bacterial fermentation into 15 L pilot bioreactors and scaled to 650 L.
  • Doubled manufacturing capacity through equipment repairs and qualification.
  • Led a $3M equipment upgrade across bioreactors, centrifuges, and lyophilizers.
  • Implemented a 21 CFR Part 11-compliant CMMS and reliability program.
2016–2019

Manufacturing Engineer

AstraZeneca · Redwood City, CA

  • Implemented a new API line and reduced campaign deviations by 93%.
  • Increased weekly output by 60% using existing equipment and headcount.
  • Improved batch success from 88% to 97% and cut changeover from three weeks to one.
  • Led continuous process validation and manufacturing documentation improvements.
2013–2016

Process Engineer

Bayer · Berkeley, CA

  • Delivered analytical-equipment CAPEX projects up to $1M within 5% of budget.
  • Established commercial process ranges through statistical analysis.
  • Led replacement of more than 100 obsolete instruments.
  • Trained more than 300 operators and technicians.

Process equipment

  • Bioreactors
  • Centrifuges
  • Homogenizers
  • TFF
  • Sterile filtration
  • Lyophilizers
  • Spray dryers
  • CIP skids
  • Clean utilities
  • Washers & autoclaves

Software & systems

  • Excel
  • Ignition SCADA
  • Power BI
  • Python
  • JMP
  • SQL
  • SAP
  • FactoryTalk
  • TrackWise
  • CMMS

Education

B.S. Bioengineering & Materials EngineeringUC Berkeley · 2013

Lean Six Sigma Green BeltIIE · 2015

Google Data Analytics Certificate2023