Work Preference
Summary
Overview
Work History
Education
Skills
References
Languages
Professional Strengths And Skills
Timeline
Generic
JAIZA R. VÉLEZ PÉREZ
Open To Work

JAIZA R. VÉLEZ PÉREZ

Guaynabo,Puerto Rico

Work Preference

Job Search Status

Open to work
Desired start date: Open to discussion

Desired Job Title

Senior Scientist – ValidationsPrincipal ScientistSenior Validation Engineer

Work Type

Full TimeConsulting

Location Preference

HybridRemoteOn-Site
Location: Guaynabo, Puerto RicoSan Juan, Puerto Rico
Open to relocation: No

Salary Range

$115000/yr - $200000/yr

Important To Me

Work-life balanceCompany CultureFlexible work hoursPersonal development programsHealthcare benefitsWork from home optionPaid time offTeam Building / Company RetreatsPaid sick leave401k matchStock Options / Equity / Profit SharingCareer advancement

Summary

Results-driven professional with over 10 years of experience in computerized systems implementation, engineering, and validation within the pharmaceutical, medical device, and biotech industries across Puerto Rico and the U.S. Proven expertise supporting Technical Services, Commissioning and Qualification, Automation, and IT teams, while ensuring full compliance with FDA regulations. Known for delivering accurate, timely documentation in fast-paced, deadline-driven environments. Recognized for a diplomatic, discreet approach to handling sensitive information, and for collaborating effectively across all organizational levels.

Overview

14
14
years of professional experience

Work History

Senior Validation Scientist (Consultant)

Boston Scientific
Dorado
11.2025 - Current
  • Developed and executed test protocols for system verification.
  • Conducted validation studies for new and existing products.
  • Collaborated with cross-functional teams on project timelines.
  • Ensured adherence to regulatory guidelines throughout processes.
  • Developed and executed validation protocols for process and equipment qualification.
  • Identified potential areas of improvement in current validations processes and proposed solutions accordingly.
  • Developed SOPs related to validation processes and procedures.
  • Created detailed reports summarizing validation activities, findings, and conclusions.
  • Performed risk assessments to identify potential areas of concern in manufacturing processes.

Senior Scientist – Validations

Bristol Myers Squibb
Manatí
08.2021 - Current
  • Coordinated the Site Equipment Periodic Assessment Program to maintain validated/qualified status, and compliance.
  • Conducted annual reviews of validation programs per the Validation Master Plan, and updated procedures accordingly.
  • Supported annual product quality review (APQR) activities for finished products.
  • Developed, scheduled, and executed projects aligned with regulatory requirements and BMS policies.
  • Executed qualification and validation activities per protocols, and provided technical support to users.
  • Identified and implemented improvements to periodic assessment reports and validation processes.
  • Assisted with quality investigations, ensuring timely closure, and effective corrective actions.
  • Supported smoke profile studies and equipment revalidation.
  • Implemented CSV activities for BioTec Liquid Handling Software for the QC Analytical Microplate Washer.
  • Led the CSV implementation for ColdStream Cold Chain Manager in QC, Incoming, and Laboratory Areas.
  • Owned validation for Vial Depyrogenation Tunnel equipment and Process Automation System (PAI, FDA remediation).
  • Developed lifecycle documentation, SOPs, and CSV for PAS/Historian modifications in the Parenteral Syringe Area to reduce downtime and increase reliability.
  • Implemented PAS Batch Detail Reports for the Parenteral Vial Area 2.
  • CSV/Data integrity remediation for the Vial Depyrogenation Tunnel in the Parenteral Vial Area 2.
  • Supported documentation for OSI PI Historian Virtual Infrastructure implementation.

Validation Specialist 2 (Contractor for Bristol Myers Squibb)

JC Automation
05.2019 - 08.2021
  • Developed lifecycle documentation and support CSV activities across site systems.

Validation Specialist (Contractor for Janssen Ortho Biologics)

JC Automation
Manatí
01.2018 - 05.2019
  • Developed lifecycle documentation for Windows 10 migration to laboratory equipment (LabX, Densitometers, Tecan Air LiHa).
  • Upgraded laboratory systems for compliance and reliability; perform CSV of ThinManager infrastructure.
  • Supported documentation for Environmental Monitoring System implementation and Chillers Building Management System modification.
  • Coordinated CSV and SOP development for OBI Manufacturing Network.
  • Validated Manufacturing LAN core switch upgrade, data storage replacement, and VMware upgrade projects.

Validation Specialist (Contractor for Intarcia Therapeutics)

JC Automation
Hayward
01.2018 - 05.2019
  • Managed documentation preparation/execution processes and drive improvements.
  • Oversaw documentation status to ensure timely completion and delivery.
  • Developed SOPs for OSI PI Historian with visual aids and step-by-step instructions.
  • Integrated stability, environmental monitoring, and materials management equipment to OSI PI Room Monitoring System.
  • Developed change requests and project plans for OSI PI – Kaye RF ValProbe integration.
  • Developed lifecycle documentation and qualification for OSI PI – Kaye RF ValProbe integration.
  • Validated integration of controlled equipment (stability chambers, HVAC, freezers, refrigerators, incubators) to OSI PI Room Monitoring System.

Validation Specialist (Contractor for Janssen Ortho Biologics)

JC Automation
Manatí
10.2013 - 08.2016
  • Developed lifecycle documentation for Windows 7 upgrades to laboratory equipment (Integra Barcode Verifier, Dionex 3000 Ion Chromatography, Kaye Validator 2000, Sotax HT100).
  • Developed SOPs and work instructions for the OSI PI Room Alarm Monitoring System.
  • Led the implementation and improvements in document preparation and execution.
  • Tracked document progress and ensure timely completion; follow up with reviewers and approvers.
  • Developed SOPs for the manufacturing network (configuration/application guidelines, with visual aids).

Validation Specialist (Contractor for McNeil Healthcare LLC)

JC Automation
Las Piedras
01.2012 - 12.2014
  • Managed change management processes (initiation, development, revision, implementation of change requests, GMP documentation).
  • Developed document control systems to log, track, and coordinate documents with service providers.
  • Defined change management strategy; assess organizational impact; monitor/evaluate performance post-implementation.
  • Prepared documentation/evidence for Consent Decree remediation work plan (achieved approvals ahead of deadline).
  • Improved batch record review/release tracker for visibility across PR and US sites; reduce approval/release time.
  • Captured decision trail and supporting information to track progress against product delivery promise dates.
  • Maintained shared view of open items, status, and actions across virtual production team.
  • Reviewed event information (type, root cause, recurring) to facilitate release process.

Validation & Change Control Specialist (Contractor for Janssen Ortho Pharma)

JC Automation
Gurabo
04.2013 - 10.2013
  • Developed CSV documentation for the OSI PI system qualification.
  • Qualified infrastructure (physical/virtual servers) with server/client installation.
  • Implemented processes/tools, provide reports, maintain/update electronic systems, and ensure documentation accuracy.

Education

Bachelor of Science - Chemistry

Interamerican University of Puerto Rico
San Juan, PR
01.2013

Bachelor of Business Administration - Marketing Management

University of Puerto Rico
San Juan, PR
01.2011

Skills

  • Data integrity and compliance
  • Computerized systems validation
  • Equipment qualification
  • Lifecycle management
  • Change control and CAPA
  • Preventive maintenance
  • Standard operating procedures (SOPs)
  • Process investigations
  • Regulatory expertise
  • CGMP and ISO standards
  • OSHA compliance
  • 21 CFR Part 11 knowledge
  • Team management skills
  • Effective communication
  • Analytical abilities
  • Organizational proficiency
  • Presentation expertise
  • Technical writing skills
  • Risk management strategies
  • Quality investigations

References

Available upon request

Languages

  • English, Fluent
  • Spanish, Fluent

Professional Strengths And Skills

  • Data Integrity and Computerized Systems Validation/Compliance
  • Equipment Qualification & Lifecycle Management (Periodic Review, Revalidation)
  • Change Control, CAPA, Preventive Maintenance, SOPs, Process Investigations
  • Experience in Pharma, Biologic, Manufacturing, and Medical Device sites (FDA & ISO regulations)
  • Strong regulatory experience (cGMP, ISO, OSHA, 21 CFR Part 11)
  • Team/people management; communication; analytical; organizational; presentation skills
  • Excellent technical writing; risk management expertise
  • Lead Quality Investigation Certification

Timeline

Senior Validation Scientist (Consultant)

Boston Scientific
11.2025 - Current

Senior Scientist – Validations

Bristol Myers Squibb
08.2021 - Current

Validation Specialist 2 (Contractor for Bristol Myers Squibb)

JC Automation
05.2019 - 08.2021

Validation Specialist (Contractor for Janssen Ortho Biologics)

JC Automation
01.2018 - 05.2019

Validation Specialist (Contractor for Intarcia Therapeutics)

JC Automation
01.2018 - 05.2019

Validation Specialist (Contractor for Janssen Ortho Biologics)

JC Automation
10.2013 - 08.2016

Validation & Change Control Specialist (Contractor for Janssen Ortho Pharma)

JC Automation
04.2013 - 10.2013

Validation Specialist (Contractor for McNeil Healthcare LLC)

JC Automation
01.2012 - 12.2014

Bachelor of Science - Chemistry

Interamerican University of Puerto Rico

Bachelor of Business Administration - Marketing Management

University of Puerto Rico

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JAIZA R. VÉLEZ PÉREZ