Name: Ivaylo Valirov
Email: ivaylo.valirov@gmail.com
Experience:
Process Engineering
Manufacturing Engineering
Project Management
Skills
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
Experience
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.
Process
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
Validation Master Plan, User Requirements Generation, IOPQ Protocol Generation and Execution, Traceability, FMEA Risk Management
Technical Writing
Identification and generation of manufacturing documentation: procedures, job aids, diagrams, training material
Equipment
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
Lil Q-tip
Patriotic Eagle
Space Shuttle
1989 Batman Batwing
