Hi! I am Ivaylo.

Name: Ivaylo Valirov

Email: ivaylo.valirov@gmail.com


Process Engineer

Manufacturing Engineer

Project Manager


Lean Manufacturing

Six Sigma

Process Development and Scale Up

Project Management

Root Cause Determination and CAPA

Quality Management

Pharmaceutical GMP

Equipment Selection and Lifecycle Management

About me

I currently work as a Senior Engineer leading the setup of an biopharmaceutical pilot facility in the San Francisco Bay Area. I have over a decade of experience in bioprocessing and pharmaceuticals and have worked on injectable drugs, inhalable drugs, pharmaceutical and food enzymes, and cultivated meat products. My expertise ranges from small scale lab scale development to large scale commercial manufacturing in regulated environments. I am passionate about process improvement, data analytics and driving efficiency.

I have expertise with the following equipment.

  • Single Use and Stainless Steel Bioreactors
  • Centrifuges
  • Homogenizers
  • TFF Skids
  • CIP Skids
  • Lyophilizers
  • Spray Dryers
  • Clean Utilities


I have specialized experience to help you navigate the complex challenges facing biopharmaceutical development and manufacturing. Whether you're seeking to optimize your processes, ensure regulatory compliance, or drive innovation in biopharmaceutical production, I am here to guide you through every step of the way.

Leveraging a blend of analytical skills, cutting-edge techniques, and a passion for problem-solving, I provide tailored solutions that not only meet the unique needs of your projects but also enhance efficiency, quality, and sustainability. From process design and optimization to quality assurance, I can cover all aspects of biopharmaceutical engineering.


DoE, CPP and KPP determination, PAT, Tech Transfer, SPC, Capability Analysis, Control Strategy, Process Robustness

Project Management

Planning, time and resource management, stakeholder management, procurement, effective communication


Validation Master Plan, User Requirements Generation, IOPQ Protocol Generation and Execution, Traceability, FMEA Risk Management

Technical Writing

Identification and generation of critical documentation: procedures, job aids, diagrams, training material


Equipment sizing, vendor selection, quote review, procurement, installation, operation and maintenance strategy, decommisioning

Asset Management

Select, implement and validate a comprehensive solution for management of all assets under a single system.

Personal Interests

I enjoy playing with my Corgi and Maltipoo.

I'm an avid Lego and puzzle enthusiast. Please enjoy some of my work below.

Cherry Blossom Corgi

Pet / 2024

101 Pooping Dogs

Puzzles / 2024

Patriotic Eagle

Puzzle / 2022

Space Shuttle

Lego / 2023

1989 Batman Batwing

Lego / 2022

Millenium Falcon

Lego / 2022