HECTOR G. SANTIAGO-TORRES
Sanford,NC
Summary
Results-driven Senior Computer Systems Validation (CSV) Engineer with over 20 years of progressive experience in FDA-regulated pharmaceutical, biotech, and medical device industries. Dedicated to ensuring regulatory compliance and adherence to the Computer System Life Cycle (CSLC) throughout all validation phases for IT and automation systems. Expertise includes V-Model, Agile/Scrum, hybrid, and risk-based validation methodologies, supported by a strong commitment to right-first-time execution and continuous improvement. Proven track record in developing, executing, and managing validation strategies and protocols for GxP computerized systems, including PAS-X MES, ICE, VDS/BMS, and various electronic document management systems (eDMS). Adept at collaborating with cross-functional stakeholders to foster a quality-focused culture from project initiation through go-live, consistently delivering compliant documentation that meets rigorous regulatory standards.
Overview
1
1
Certification
22
22
years of professional experience
Work History
Senior Computer Systems Validation Consultant
PHARMENG
Durham, NC
04.2022 - Current
- Develop and execute validation strategies for laboratory, manufacturing, and quality systems in compliance with GAMP 5 and applicable regulatory requirements.
- Author and execute validation documentation, including Validation Plans, Risk and Impact Assessments, IQ/OQ protocols, Traceability Matrices, and Summary Reports, upholding right-first-time documentation practices and GxP quality standards.
- Implement a hybrid validation framework combining V-Model and Agile (SCRUM) methodologies to support system lifecycle flexibility for new projects.
- Lead Agile SCRUM-based validation of LabVantage LIMS, increasing validation transparency and improving stakeholder collaboration throughout the project lifecycle.
- Validate cloud-based Veeva Quality and Training systems, including hyper-care monitoring and post-go-live change management activities.
- Provide technical guidance to IT and Quality teams on validation lifecycle best practices and regulatory expectations, fostering a culture of quality and continuous improvement across project teams.
- Lead validation efforts for PAS-X MES, Octoplant, VDS/BMS, and ICE Equipment Log systems across multiple client engagements.
- Develop Automation Commissioning Testing Protocols (ACTP) to verify that alarms generated via DeltaV DCS and the site VDS are properly configured, accurately logged in PI Historian, and correctly received in ICE and TopView as applicable.
- Clients: Greenlight Biosciences (Remote) | Fujifilm Diosynth Biotechnologies (Hybrid, NC)
Compliance Manager
PFIZER INC.
Sanford, NC
10.2004 - 04.2022
- Actively participated in regulatory inspections and internal audits by defending validation documentation and quality-focused compliance strategies before regulatory authorities.
- Developed semi-automated inspection readiness data-mining solutions, reducing manual effort by 60%.
- Reduced audit response time to under one hour for 70% of validation deliverable requests, significantly improving inspection outcomes.
- Standardized global inspection readiness documentation processes across multiple business units, ensuring consistency, regulatory alignment, and adherence to GxP quality system requirements.
- Compliance Manager April 2016 – October 2021
- Senior Computer Systems Validation Engineer June 2011 – April 2016
- Managed and executed validation and change control activities for enterprise-level computer systems in a GxP-regulated environment.
- Reduced first-time quality errors by 30% by redesigning validation review workflows and embedding right-first-time principles into the review process.
- Developed automated change control visualization tools that reduced review time by 75%, streamlining cross-functional decision-making.
- Managed cross-functional validation teams during global inspection readiness initiatives, ensuring timely delivery of audit-ready documentation.
Computer Validation Engineer
Computer Validation Engineer
Sanford, NC
10.2004 - 06.2011
- Executed full lifecycle validation for laboratory, quality, and enterprise computer systems within an FDA-regulated pharmaceutical manufacturing environment, ensuring right-first-time execution and continuous alignment with quality system requirements.
- Authored and executed IQ/OQ/PQ protocols, Traceability Matrices, Deviation Reports, and Validation Summary Reports across multiple system implementations.
- Defended validation strategies and supporting documentation during Board of Health regulatory inspections.
- Managed validation contractors supporting DeltaV DCS and OSIsoft PI system implementations, ensuring deliverables met quality and timeline requirements.
- Validated systems including Statistica, LabWare LIMS V5, Sparta TrackWise, Document Management Systems, and electronic laboratory notebooks (eLN).
- Collaborated with cross-functional teams to identify and resolve validation-related issues during project lifecycles.
- Reviewed and approved validation deliverables, ensuring accuracy and adherence to industry guidelines.
Education
Master of Business Administration (MBA) - Management & Strategic Leadership
AGM University
Puerto RicoBachelor of Science in Electrical Engineering (BSEE) - Power Systems
University of Puerto Rico
MayagüezSkills
- Computer Systems Validation (CSV)
- GAMP 5 Framework
- Risk Assessments (Risk-Based Validation)
- IQ / OQ Protocol Development & Execution
- Traceability Matrix Development
- Change Control & Deviation Management
- Data Integrity (ALCOA)
- Inspection & Audit Support
- Agile (SCRUM) & V-Model Validation
- Quality Culture & Continuous Improvement
- LabVantage LIMS LabWare LIMS
- Veeva QualityDocs ePALMS eLN
- PAS-X MES Octoplant VDS/BMS
- ICE Statistica CMMS
- Kneat Gx TrackWise HP Service Manager
- Microsoft Power Automate Power Apps SharePoint
Certification
- Licensed Professional Engineer (PE) — Active in North Carolina and Puerto Rico
- ASQ Certified Software Quality Engineer (CSQE)
- Certified SCRUM Master
Languages
English
Spanish
Timeline
Senior Computer Systems Validation Consultant
PHARMENG
04.2022 - Current
Compliance Manager
PFIZER INC.
10.2004 - 04.2022
Computer Validation Engineer
Computer Validation Engineer
10.2004 - 06.2011
Master of Business Administration (MBA) - Management & Strategic Leadership
AGM University
Bachelor of Science in Electrical Engineering (BSEE) - Power Systems
University of Puerto Rico
Licences & Certifications
- Licensed Professional Engineer (PE) — Active in North Carolina and Puerto Rico
- ASQ Certified Software Quality Engineer (CSQE)
- Certified SCRUM Master