LUIS G. REYES MORALES
Engineer • Validator • Problem Solver
Senior IT Analyst, Manufacturing Engineering & Validation Expert
Ponce, Puerto Rico
20+
Years Experience
$21K+
Cost Savings
52+
Systems Upgraded
2
Engineering Degrees
15+
Certifications
ENGINEER FOCUSED ON COST EFFECTIVE PROCESSES AND CONTINUOUS IMPROVEMENT METHODS with expertise in Lean Manufacturing, Kaizen, Project Management, Mechanization and Automation.
Professional Manufacturing/Supporting Engineering with 20 years of experience in medical devices and Network Infrastructure Systems with strong project management capabilities, team building skills, and expertise in productivity improvements, cost reduction, lean manufacturing, validation support, and creative problem solving.
Core Expertise
Process Optimization
Effective strategies for productivity improvements, cost reduction, and lean manufacturing implementation
Validation & GMP
Computer System Validation (CSV SME), GxP implementation, cleanroom protocols, and regulatory compliance
Manufacturing Engineering
CNC manufacturing, PLC systems, automation, and mechanization solutions
IT Infrastructure
Network systems, server management, active directory, and system recovery
Team Leadership
Team development, project management, conflict resolution, and cross-functional collaboration
Quality Systems
5S procedures, Kaizen, DMAIC method, and functional excellence
Professional Experience
Multi-Professional Consultant
Independent Professional Services
2023–Present
Ponce, Puerto Rico
- Professional Home-Property Inspector (NACHI PR82464) – Comprehensive property inspections and assessments
- Home Power Sun Energy Consultant by SUNRUN – Solar energy system design and implementation
- Real Estate Broker (License: C-24649) – Property management and real estate transactions
Sr. Remediation Validation Engineer
Pfizer Hospira Pharmaceuticals
2019–2020
McPherson, Kansas
Key Accomplishments:
- Supported qualification tasks for remediation validation protocols including AutoClave Bowie Dick, leak testing, and Kaye Validation configuration
- Coordinated thermocouple (TC) calibration and load configuration optimization for cycle development
- Managed autoclave runs, data analysis, and chart development for all sterilization stages (preconditioning, heating, exposure, post-condition)
- Executed cleanroom protocols using QTS, TrackWise, and CAPA systems
- Performed aseptic technique validations: sterile gloves, gowns, drapes, smoke tests with Vegas 16 video editing, and laminar flow pattern verification
Quality System Expert – Process & Products
Baxter Regional Medical Center
2018
Jayuya, Puerto Rico
Validation & Quality Support:
- Supported qualification for remediation validation protocols, commissioning, and final reports for AutoClave, Rotary Ring Printers, and cleanroom protocols
- Managed POMS inventory, InfinityQS, and TeamCenter Documentation (TCU) systems
- Executed comprehensive environmental controls: smoke tests, pattern flow laminar, differential pressure studies, temperature studies, particle counting
- Performed aseptic technique validations and quality support for sterile manufacturing operations
Qualification Engineer – FMT Technical Services
Sartorius-Stedim Filters, Inc.
2017
Yauco, Puerto Rico
Process Improvement & Validation:
- Supported qualification tasks for new upcoming equipment implementation
- Team member for Good Manufacturing Practice (GxP) implementation
- Implemented Lean Metrics reducing lead time by 50% using DMAIC methodology
I.T. Support Sr. Technician – Manufacturing Engineering
Zimmer Biomet
1999–2016
Ponce, Puerto Rico
17 Years of Excellence – Major Achievements:
- Computer Validation Subject Matter Expert (CSV SME) – Led GxP and Computerized System Validation implementation
- $21,000 Cost Savings Project – Upgraded 52+ Factory Net CNC machines from RS232 to Ethernet, minimizing downtown communications and reducing multiport card costs
- Managed GMP Documentation Online Project improving communication and compliance across manufacturing operations
- Designed custom workbenches for computers and monitors to reduce ergonomic issues (JD Edwards and EDGAR Projects)
- Engineer support for Quality Sourcing Department performing validation for CNC machines and computer systems
- Led WERMA Implementation for production monitoring across all CNC machines
- Implemented OEE (Vorne XL) at Hip Poly project pilot for overall equipment effectiveness tracking
- Supported continuous improvement projects for cost reduction, productivity improvement, ergonomics, and safety
Production Operator
Tubed Product, Inc.
1991–1993
Easthampton, Massachusetts
- Supervised all plastics production operations
- Trained employees with no computer experience on manufacturing systems
Education
Bachelor of Science
Mechanical Engineering
Polytechnic University, Hato Rey, P.R. | 2014
Bachelor of Science
Computer Science
Interamerican University, Ponce, P.R. | 1998
Second Major: Technology Electronic Engineering
Interamerican University, San German, P.R.
Interamerican University, San German, P.R.
Technical Skills & Competencies
Operating Systems
Engineering Software
Business Applications
Hardware & Infrastructure
Manufacturing & Validation
Core Competencies
Languages
Certifications & Professional Training
Computer Validation Training
APDC | 2009 | 32 hours completed
www.apdcpr.com
www.apdcpr.com
Industrial Validation Academy
VANDA Scientific Corp. | 2016 | 32 hours
Comprehensive validation process training
Comprehensive validation process training
ASQ Certified Quality Engineer Academy
American Society for Quality | 3.5 CEU
CompTIA A+ Certified
ID: COMP10377921
Verification: f6cdtt0594
Verification: f6cdtt0594
Steris University – Steam Sterilization
11.5 CE Hours | Multiple courses:
Basic Principles, Monitoring, Biological & Chemical Indicators
Basic Principles, Monitoring, Biological & Chemical Indicators
Microsoft Certifications
Courses: 6421A, 6425B, 6294A
FCC General Radio Operator License
GROL OF FCC #PG-GB-034829
ChatGPT & AI Training
G-Talent.net:
• ChatGPT for Finance (5 Hours)
• Prompts Engineering (2 Hours)
• ChatGPT for Finance (5 Hours)
• Prompts Engineering (2 Hours)
Web Development in WordPress
G-Talent.net | 4 hours
NACHI Professional Home Inspector
Certification ID: PR82464
Real Estate Broker License
License: C-24649
State of Puerto Rico
State of Puerto Rico
Engineer in Training (E.I.T.)
In Progress – Pursuing Certification
Awards & Recognition
Impact Award
“Win through Results”
“Win through Results”
Zimmer Biomet | 2016
Impact Award
“Demonstrating Our Values”
“Demonstrating Our Values”
Zimmer Biomet | 2015
Professional Memberships & Affiliations
ASME Member
American Society of Mechanical Engineers
Member #8638702
Member #8638702
NSPE Member
National Society of Professional Engineers
Sigma Kappa Chi
Professional Engineering Fraternity
Real Estate Professional
Keller Williams
Property & Rental Management
Property & Rental Management
Solar Energy Consultant
HomePower by SUNRUN
Renewable Energy Solutions
Renewable Energy Solutions
Professional Value Proposition
💡
Dual Engineering Expertise
Mechanical Engineering + Computer Science = Unique problem-solving approach
✅
Validation Specialist
CSV SME with GxP, cleanroom, and sterilization expertise
📊
Proven Cost Reducer
$21K+ savings through strategic system optimization
🎯
Lean Manufacturing Expert
50% lead time reduction using DMAIC methodology
🔧
Multi-Industry Experience
Medical devices, pharmaceuticals, and industrial manufacturing
🌐
Bilingual Professional
Fluent English & Spanish for global collaboration
Ready to deliver engineering excellence with proven results in manufacturing, validation, and process optimization.
20+ years of continuous innovation • Multiple certifications • Award-winning performance
References and detailed project portfolios available upon request
Updated: January 2025 • Professional CV • Luis G. Reyes Morales