Functional Skills
Quality Management
Sterilization
Data Migration
Compliance and risk
User Acceptance Testing
Technical Writing
Quality Assurance
QA Testing
Project Management
Software Skills
Microsoft Access
Microsoft Edge
Microsoft Excel
Microsoft Excel Macros
Microsoft Office
Microsoft PowerPoint
Microsoft Project
Microsoft Visio
Microsoft Word
Sector Experience
Life Sciences & Pharma
Manufacturing
Technology
Languages
English
Russian
Experience
U.S. Validation Services LLC
Engineering
Principle Consultant
2/2009 - 1/2024
Delivering validation and cGMP compliance consulting services to pharmaceutical, biotechnology, and medical device companies. Successfully completed the following projects:
Amgen Woburn Mass.
Engineering
former BioVex
9/2012 - 1/2016
• Participated in FDA, EMA, and TGA pre-approval inspections for the T-VEC product (the first oncolytic herpes virus approved by the US FDA).
• Authored Facility and Utility Systems Validation Plans and reviewed validation and commissioning documents for BMS, CMS, and Utility systems.
• Contributed to the facility upgrade project, including Quality Risk assessments and validation.
• Performed Part 11 assessments for various equipment and instrumentation in compliance with 21 CFR, as well as participated in the implementation of the data integrity and security remediation plan.
• Had responsibility for the site qualification of the Werum PAS-X MES System, including drafting Site Validation Plans, and Site qualification protocols for multiple Electronic Batch Records (EBRs).
• Conducted a Disinfectants Efficacy Study for an aseptic fill line.
• Developed User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), and successfully validated an Automated Fi
• Authored Facility and Utility Systems Validation Plans and reviewed validation and commissioning documents for BMS, CMS, and Utility systems.
• Contributed to the facility upgrade project, including Quality Risk assessments and validation.
• Performed Part 11 assessments for various equipment and instrumentation in compliance with 21 CFR, as well as participated in the implementation of the data integrity and security remediation plan.
• Had responsibility for the site qualification of the Werum PAS-X MES System, including drafting Site Validation Plans, and Site qualification protocols for multiple Electronic Batch Records (EBRs).
• Conducted a Disinfectants Efficacy Study for an aseptic fill line.
• Developed User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), and successfully validated an Automated Fi
Control Quest, I nc.
Engineering
Sr. Consultant
1/2001 - 1/2009
Delivered validation consulting services to organizations in the pharmaceutical, biotechnology, and medical device sectors. Completed the following projects:
Circe Biomedical Lexington
Engineering
Validation Manager
1/2000 - 1/2001
Supervised a team of validation engineers and technicians. Developed and implemented Validation, Change Control, and Metrology Programs for the production of isolated, purified, and preserved mammalian cells, as well as for the fabrication of semi-permeable, biocompatible membranes.
• Achieved cGMP compliance for the production facility to support Phase I I/I I I clinical trials across the United States and Europe.
• Actively participated in the preparation of CM&C submissions.
• Formulated a strategy for Part 11-21CFR software compliance.
• Prepared a comprehensive Validation Master Plan for the Production Facility.
• Developed a comprehensive set of validation protocols and SOPs for various critical systems, including Pharmaceutical Grade Water systems, HVAC systems, Clean Rooms, Steam Sterilizers, Computerized Systems, and other production equipment.
• Achieved cGMP compliance for the production facility to support Phase I I/I I I clinical trials across the United States and Europe.
• Actively participated in the preparation of CM&C submissions.
• Formulated a strategy for Part 11-21CFR software compliance.
• Prepared a comprehensive Validation Master Plan for the Production Facility.
• Developed a comprehensive set of validation protocols and SOPs for various critical systems, including Pharmaceutical Grade Water systems, HVAC systems, Clean Rooms, Steam Sterilizers, Computerized Systems, and other production equipment.