2021 -2025 Sr. Director QA Validation and Engineering @
2018 -2021 Director CQV Manufacturing Operations @
2014 -2021 Advisory Board Member and Managing Editor @
2016 -2018 Director Client Engagement and Product Strategy @
2014 -2016 Director, QA Validation @
2011 -2014 Associate Director @
2006 -2011 Sr. Manager Validation @
2004 -2006 Manager IT Compliance and Validation @
2001 -2004 Information Technology Compliance Manager @
1999 -2001 Consultant @
Ivan Soto Education
Polytechnic University Of Puerto Rico - Hato Rey
Bachelors (Electrical Engineering)
1983-1989
Polytechnic University of Puerto Rico
Universidad Politécnica de Puerto Rico
Bachelor of Science in Electrical Engineering (Electrical Engineering)
Ivan Soto Skills
CAPA
Quality Systems
Document Management
GxP
Change Control
GMP
Biopharmaceuticals
21 CFR Part 11
GAMP
Quality System
Validation
Regulatory Requirements
Delta V
Quality Assurance
Biotechnology
Quality Auditing
Computer System Validation
GLP
Process Logix
Regulatory Affairs
V&V
FDA
Process Simulation
Pharmaceutical Industry
Regulatory Submissions
LIMS
Sop
ISO 13485
Trackwise
Cleaning Validation
Aseptic Processing
Lifesciences
GCP
Technology Transfer
HPLC
Clinical Trials
Chromatography
Analytical Chemistry
Purification
CRO
Vaccines
CMC
Fermentation
SOP development
Pharmaceutics
Clinical Development
IND
Drug Development
Life Sciences
Data Validation
Microsoft Word
PowerPoint
Microsoft Office
Microsoft Excel
Customer Service
Preventive Maintenance
Project Planning
Process Scheduler
Electricians
Maintenance and Repair
Leadership
Predictive Maintenance
Engineering
Steam
Root Cause Analysis
Manufacturing
Management
Process Engineering
Continuous Improvement
Process Improvement
Business Process Improvement
Preventative Maintenance
Effective Kpis
Manufacturing Best Practices
Equipment Specialist
Peak Performance Output
Environmental Standards
Federal Regulation
Cross Functional Leader
SME
Vendor Collaboration
Training Courses
Service Level
Minitab
AutoCAD
Viso
Nfpa 70e
MS Office Suite
MS Project
Stakeholders
Contractors
Room Environmental Conditions
Air Flow Pattern
Certification Programs
Asepctic Rooms
Ivan Soto Summary
Ivan Soto, based in Lynnfield, MA, US, is currently a Director IT Digital Quality and Governance at Dyne Therapeutics. Ivan Soto brings experience from previous roles at Strategic Consulting Services, Sarepta Therapeutics, Emergent BioSolutions and Advanstar. Ivan Soto holds a 1983 - 1989 Bachelors in Electrical Engineering @ Polytechnic University Of Puerto Rico - Hato Rey. With a robust skill set that includes CAPA, Quality Systems, Document Management, GxP, Change Control and more. Ivan Soto has 3 emails and 2 mobile phone numbers on RocketReach.
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