Project Manager

DAVRON CV: Candidate 1919919

VALIDATION PROJECT MANAGER | CSV, CLEANING VALIDATION & EQUIPMENT QUALIFICATION

Core Expertise

• Leading validation programs across pharmaceutical, biotech, and medical device environments.
• Developing CSV and process validation SOPs, protocols, and lifecycle documentation.
• Managing equipment qualification, cleaning validation, CIP/SIP, and automation qualification activities.
• Driving regulatory compliance with cGMP, FDA, EMA, and ICH across validation projects.
• Implementing validation simplification strategies yielding approximately 40% reduction in validation effort.
• Managing budgets up to $20M and coordinating multi-vendor teams for complex projects.

Project Background

• Established validation departments and built SOP/protocol templates for new and existing sites.
• Led CSV and computer system validation for MES, LIMS, KNEAT, Veeva, and SaaS COTS systems.
• Coordinated qualification and requalification projects for process equipment and automation systems.
• Managed resource allocation, vendor coordination, schedules, and deliverables for on-time project completion.
• Prepared regulatory inspection packages and supported successful FDA/EMA inspection readiness activities.

Key Skills

• Validation lifecycle management | Cleaning validation design and execution | Equipment qualification | CIP/SIP programs
• Computer system validation (CSV) | KNEAT | Veeva | Trackwise | MES | SmartSolve
• Regulatory compliance | cGMP | FDA | EMA | ICH | 21 CFR | Data integrity
• Project management | Budgeting | Resource allocation | Vendor management | Risk mitigation
• Documentation & SOP development | Protocols | Closeout packages | Change control
• MS Project | Excel | Visio | Minitab | Documentum | Windchill | ADAPTIV

Education

• B.S., Chemical Engineering — City College of New York (CUNY)

Awards & Recognition

• Project Management Professional training (PMP) with formal project controls and scheduling coursework
• Member, International Society for Pharmaceutical Engineering (ISPE); engagement in industry best practices
• ICH Q7 and SUPAC training; GAMP exposure and pharmaceutical process development coursework

Why Interview this Candidate?

A seasoned validation project manager with 22+ years delivering CSV, cleaning validation, and equipment qualification in regulated environments. Proven track record establishing validation departments, streamlining validation programs (≈40% reduction in effort), and managing multi-vendor projects and budgets up to $20M. Brings strong regulatory inspection readiness, SOP development, and cross-functional leadership to accelerate validation delivery and compliance.