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I am a QA-Validation Engineer with over 14 years of experience in the pharmaceutical and medical device industries. I specialize in CSV, CSA, automation, and supplier assessment, with a strong focus on regulatory compliance and data integrity in cGMP/GLP environments. I thrive on cross-functional collaboration, risk-based validation, and delivering robust, scalable manufacturing and IT systems. I am skilled in leading validation projects, implementing automation and SaaS integrations, and applying IT controls to ensure regulatory compliance. I enjoy translating complex requirements into practical validation deliverables, training end-users, and driving continuous improvement to improve product quality, traceability, and business continuity.…I am a QA-Validation Engineer with over 14 years of experience in the pharmaceutical and medical device industries. I specialize in CSV, CSA, automation, and supplier assessment, with a strong focus on regulatory compliance and data integrity in cGMP/GLP environments. I thrive on cross-functional collaboration, risk-based validation, and delivering robust, scalable manufacturing and IT systems. I am skilled in leading validation projects, implementing automation and SaaS integrations, and applying IT controls to ensure regulatory compliance. I enjoy translating complex requirements into practical validation deliverables, training end-users, and driving continuous improvement to improve product quality, traceability, and business continuity.

Ramin Shirzai

QA Engineer, AI Engineer, Data Scientist, +2

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I am a QA-Validation Engineer with over 14 years of experience in the pharmaceutical and medical device industries. I specialize in CSV, CSA, automation, and supplier assessment, with a strong focus on regulatory compliance and data integrity in cGMP/GLP environments. I thrive on cross-functional collaboration, risk-based validation, and delivering robust, scalable manufacturing and IT systems. I am skilled in leading validation projects, implementing automation and SaaS integrations, and applying IT controls to ensure regulatory compliance. I enjoy translating complex requirements into practical validation deliverables, training end-users, and driving continuous improvement to improve product quality, traceability, and business continuity.…I am a QA-Validation Engineer with over 14 years of experience in the pharmaceutical and medical device industries. I specialize in CSV, CSA, automation, and supplier assessment, with a strong focus on regulatory compliance and data integrity in cGMP/GLP environments. I thrive on cross-functional collaboration, risk-based validation, and delivering robust, scalable manufacturing and IT systems. I am skilled in leading validation projects, implementing automation and SaaS integrations, and applying IT controls to ensure regulatory compliance. I enjoy translating complex requirements into practical validation deliverables, training end-users, and driving continuous improvement to improve product quality, traceability, and business continuity.

Available to hire

I am a QA-Validation Engineer with over 14 years of experience in the pharmaceutical and medical device industries. I specialize in CSV, CSA, automation, and supplier assessment, with a strong focus on regulatory compliance and data integrity in cGMP/GLP environments. I thrive on cross-functional collaboration, risk-based validation, and delivering robust, scalable manufacturing and IT systems.

I am skilled in leading validation projects, implementing automation and SaaS integrations, and applying IT controls to ensure regulatory compliance. I enjoy translating complex requirements into practical validation deliverables, training end-users, and driving continuous improvement to improve product quality, traceability, and business continuity.

Skills

Experience Level

Expert

Expert

Expert

Expert

Intermediate

Intermediate

Intermediate

Intermediate

Intermediate

Language

English

Fluent

Work Experience

Senior Validation Engineer at Vectura PLC Group

December 1, 2024 - July 1, 2025

Develop and implement validation strategies for the decommissioning of legacy systems and qualification of new SaaS-based infrastructure. Lead integration projects for GitHub, GitHub Actions and GitLab to advance the Device Development Life Cycle and execute DevOps activities for CI/CD pipelines. Lead integration of MasterControl, Q-pulse and Veeva Vault to streamline workflows in line with Vectura QMS policy. Establish and maintain the Validation Master Plan for the transition; collaborate with IT, QA and Validation to identify gaps and remediation; author, review and execute IQ/OQ/PQ and risk assessments; configure AD within Veeva Vault; validate cloud data migrations and system integrations; ensure data integrity and access controls; develop training for end-users and maintain cloud-based validation.

Validation Engineer (CSV) Specialist at Albu-Medix

March 1, 2024 - December 1, 2024

Developed and maintained Validation Master Plans for PCS-7 SCADA systems; conducted regular risk assessments; created URS, FS, DS, RTM and validation summary reports; commissioned SKIDs (DE-FF2, PBA-UF and CS108); configured Active Directory; ensured 100% compliance with FDA/MHRA requirements; authored SOPs and supported supplier CSV assessments; performed data migration validation and end-user training.

CSV Specialist at AstraZeneca

January 1, 2022 - February 1, 2024

Managed full lifecycle documentation for computerized systems (Plan, URS, RTM, risk assessments, design docs, test protocols) across Drum Freezer, Freeze Dryer, Autoclave, Oven and SCADA systems; led C&Q/CSV qualification activities, deviations, changes and CAPA; performed commissioning, calibration and functional testing; raised and resolved snags; led supplier coordination and site audits; conducted risk assessments and validated test results with 95% first-time pass rate.

Computer System Validation and QA Audit Support Specialist at Pharmaserve Northwest

December 1, 2020 - January 1, 2022

Managed validation projects for software upgrades; applied risk-based CSV per EU GMP Annex 11/15 and GAMP 5; managed change controls, CAPAs and process changes; validated PEMAC/PEMAC Asset cloud-based systems including data migration and data handling; served as SME during audits and supported inspection readiness; mentored QA staff on CSV and data integrity.

Senior Batch Release & Validation Coordinator at Fresenius Kabi

June 1, 2017 - December 1, 2020

Reviewed batch documentation for product release; generated periodic validation master plan reports; investigated non-conformances and implemented CAPAs; performed commissioning on Isolator Syringe Filling System (Getinge); tested interlocks and equipment validation; led risk assessments (FMEA), created engineering drawings, validated systems and ensured ongoing revalidation; applied Six Sigma/Lean methods to improve efficiency and reduce waste.

QA Engineer at Nerudia Nicotine Manufacturing

October 1, 2016 - May 1, 2017

Reviewed validation lifecycle documents and CQV protocols; validated equipment and processes for filling, capping and labeling; coordinated validation testing schedules; supported vendor document review (FAT, SAT, P&ID, O&M); led validation testing with adherence to acceptance criteria and contributed to audit readiness.

Validation Engineer at Bryon Pharmaceutical Company

February 1, 2012 - January 1, 2015

Managed on-site validation activities for the manufacturing line (Blinding, Tablet Compressing, Blister, Heat Sealing, Packing); reviewed and executed FAT/SAT; performed commissioning and staff coordination; verified calibration of critical instruments; initiated VMP and IQ/OQ/PQ; conducted risk assessments (FMEA) and supported ongoing process improvements.

Hospital Pharmacist at KOICA South Korean Hospital

January 1, 2010 - January 1, 2012

Managed a team of 10, oversaw validation protocol development for ASC compounding machines, ensured aseptic processing and compliance with regulatory requirements; led commissioning and qualification activities; supported SOP development and audit readiness; liaised with Quality, Regulatory and Engineering teams to ensure validated operations.