Open to opportunities

Katya Zlateva

@katyazlateva

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Data Scientist and process automation engineer delivering compliant, data-driven optimization in pharma.

Bulgaria

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What I'm looking for

I’m looking for a role where I can apply statistical inference and machine learning to solve real operational problems—optimizing processes, supporting compliance, and improving decision-making—while leveraging my pharma/MedTech engineering background.

I’m a Process Development & Automation Engineer turned Data Scientist, with 10+ years in Pharma & MedTech and a recent MS in Statistics. I bring international experience across Europe and the US, combining domain expertise with statistical inference and machine learning.

In pharma and medical devices, I led product development and executed process validation, risk assessment (FMEA), and technology transfer—driving tangible outcomes like 1MM annual savings. I strengthened process capability and product quality using statistical methods such as SPC, MSA, and DOE, supported by tools like Minitab.

More recently, I’ve applied automation and control expertise to pharmaceutical environments, developing and optimizing HVAC control systems and executing commissioning (FAT/SAT) plus IQ/OQ/PQ qualification in compliance with GAMP5 guidance. I’m comfortable bridging engineering rigor with operational requirements, so data and systems translate into reliable decisions.

I also built depth through graduate-level teaching and consulting—serving as a Teaching Assistant for Probability and Statistical Inference and conducting statistical consulting to identify students at risk of dropping out. My professional ethos is simple: use evidence-based modeling and clean engineering practices to improve performance, compliance, and decision-making.

Experience

Work history, roles, and key accomplishments

Current

Automation/Controls Engineer

Current

Siemens

Mar 2025 - Present (1 year 4 months)

Develop and optimize HVAC control systems for pharmaceutical environments using cascade PID control. Execute commissioning and IQ/OQ/PQ qualification of automation systems in compliance with GAMP5 guidance.

Control Systems Process Control FAT

Sr. Process Engineer

Abbott

Aug 2019 - Dec 2023 (4 years 4 months)

Led product development of Class III implantable drug-eluting medical devices from concept through in vivo animal studies and clinical builds. Conducted characterization, process validation, risk assessment (FMEA), and technology transfer of drug products.

Medical Device Development Process Validation Risk Assessment D P FMEA Technology Transfer Minitab

Process Engineer I

Abbott

Aug 2019 - Dec 2023 (4 years 4 months)

Contributed to development and validation work for Class III implantable drug-eluting medical devices, including characterization and technology transfer. Applied statistical methods to enhance process capability and product quality.

Medical Device Development Process Validation Technology Transfer SPC Minitab

Process Engineer II

Abbott

Aug 2019 - Dec 2023 (4 years 4 months)

Supported product development for Class III implantable drug-eluting medical devices and contributed to characterization, process optimization, and validation activities. Worked on technology transfer efforts, including risk assessment and statistical quality methods.

Medical Device Development Process Validation Technology Transfer SPC Minitab

Industrialization Lead

GlaxoSmithKline

Jan 2017 - Nov 2018 (1 year 10 months)

Acted as a liaison between R&D and Global Manufacturing and Supply for dry powder inhalers from early-stage formulation development through technical transfer. Analyzed critical quality attributes using Minitab and Power BI to support management planning.

Dry Powder Inhalation Technical Transfer Stakeholder Management Minitab Power BI

Pharmaceutical Technologies Specialist

Teva Pharmaceuticals

Oct 2015 - Jan 2017 (1 year 3 months)

Designed and executed formulation and scale-up/down studies to support seamless technology transfer of solid oral dose forms to the Dupnitsa site. Coordinated cross-functional teams to prepare and review global regulatory submissions and ensure compliance.

Scaling Technology Transfer Regulatory Submissions Regulatory Compliance Cross functional Coordination

Process Engineer Co-op

Solvay

Sep 2013 - Apr 2014 (7 months)

Optimized fluoropolymer production processes to reduce batch cycle time and increase plant capacity. Supported operational improvements in a manufacturing environment.

Fluoropolymer Production Process Optimization Batch Cycle Improvements

Research & Development Engineer Co-op

Rex Medical

Jan 2012 - Jan 2013 (1 year)

Performed functional testing of vascular closure devices to support validation and verification (V&V). Contributed to testing efforts aligned to verification/validation activities.

Functional Testing Validation And Verification