Rene Medrano
Miami,Florida
Summary
Over 18 years of experience in engineering and manufacturing within pharmaceuticals, medical devices, and biopharmaceuticals. Expertise includes a comprehensive knowledge of regulatory requirements for Drugs, Food/Cosmetics, Dietary Supplements, Biologics, Devices, and Aviation. Proven track record in developing and implementing robust validation protocols to ensure process consistency and deliver high-quality products. Strong technical writing skills and adeptness in cGMP and GDP principles ensure meticulous and compliant documentation.
3.5
Overview
27
27
years of professional experience
1
1
Certification
Work History
Quality Engineer
Microvention Terumo
Miami, FL
01.2024 - 04.2024
- Conducted a comprehensive review of over 150 executed validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ) protocols, and Test Method Validations (Attribute & Variable) for manufacturing equipment and computer systems used in the production of stents, coils, and other neurovascular devices to support a VOE for a CAPA.
- Identified potential product and compliance risks, such as the lack of statistical analysis or risk assessment, incorrect conclusions, improper evaluation of deviations and failures, and unvalidated test methods.
- Enhanced VOE checklists and ensured validations were supported by accurate conclusions, addressing deviations and failures that were not properly documented or lacked evidence of validation (e.g., unvalidated rework, cleaning, and parameters).
Validation Engineer
Amsino Healthcare
Vernon Hills, Chicago
09.2023 - 01.2024
- Collaborated on remediating the qualification process for Blow Fill Seal injection machines, ensuring compliance with regulatory standards and enhancing production efficiency
- Conducted comprehensive software validation for Dicksonone real-time dataloggers, guaranteeing accurate and reliable data collection for process monitoring and control
- Spearheaded the implementation of an environmental program, including temperature mapping qualification for media fill incubators, to maintain optimal conditions for medical device production and storage.
Validation / Engineering Manager
Pure Source
Doral , FL
05.2019 - 09.2023
- Contributed to resolving a warning letter (OAI) by assisting with an engineering and validation gap remediation plan.
- Supported NDA changes (CBE-30) for Minoxidil Solution and developed/approved qualification protocols and reports for various equipment.
- Led a team of interns in drafting and executing process validation reports for OTC products.
- Established a comprehensive calibration and preventive maintenance program for equipment and instruments, enhancing traceability for validation activities.
- Collaborated with cross-functional teams to ensure validation activities met project goals.
- Implemented an environmental monitoring program with DicksonOne real-time data loggers.
- Led process improvement projects, automating semi-manual operations and introducing new methods.
- Supported regulatory inspections by providing validation documentation and assistance.
Sr. Validation Engineer Associate
PL Developments
Doral , FL
09.2017 - 09.2019
- Led the validation of a new granulation suite (High Shear granulator, Quadro Comil, Fluid Bed, vacuum transfer) across multiple sites, ensuring efficient granulation, compression, and blending processes
- Played a key role in both installation and qualification phases
- Conducted successful re-qualifications (IOPQ) on diverse manufacturing equipment and qualified four complete filing and packaging lines
- Designed and executed temperature/humidity mapping studies for bulk product storage and transport assessments
- Performed cleaning validation on equipment and actively contributed to drafting final reports for process validations (OTC, Rx, Nicotine Polacrilex).
Sr. Validation Engineer
Unipharma LLC
Tamarac, FL
09.2016 - 09.2017
- Mentored engineering interns on IQ/OQ/PQ templates while contributing to validation protocols for HVAC, compressed air, bioreactors, tanks, BFS equipment, and instruments; additionally, conducted temperature mapping validation in warehouses for optimal monitoring and accurate temperature control.
Validation Engineer
Siemens Molecular Diagnostics
Berkeley, California
03.2016 - 04.2016
- Performed Installation Qualification (IQ) for Zebra Printers generating product labels for ZIKA DNA, Hepatitis, and HIV reagents, and the VERSANT kPCR Molecular System used in sample preparation for Salmonella Gastro, ZIKA DNA, and HCV assays.
Validation Engineer
Actavis-Allergan (TEVA)
Sunrise, Florida
02.2016 - 03.2016
- Developed Standard Operating Procedures (SOPs) for Optel Pharmaproof and Line Master, delineating the process and guidelines for generating recipes for both serialized and non-serialized products across packaging lines.
Validation Engineer
Abbott Medical Optics (AMO)
Añasco, Puerto Rico
10.2014 - 12.2015
- Reviewed calibration history for 3,000+ site instruments, performed remediation as needed, and validated test methods (attribute & variable) for optical comparators, ensuring all instruments met 4:1 process and calibration accuracy ratios.
Validation Engineer
Promega Corporation
Madison, WI
10.2013 - 09.2014
- Contributed to IQ/OQ/PQ of 10 HVAC systems: Ensured compliance with ISO 7 and 8 cleanroom standards at the Feynman facility. These controlled environments supported enzyme, biotechnology, and molecular biology products, including protein analysis, cellular analysis, drug discovery, and genetic identity.
Validation Engineer
Zimmer Biomet Dental
Carlsbad, California
01.2013 - 08.2013
- Performed temperature mapping of Shel Lab Ovens for textured dental implants using a GE Kaye Validator (pre/post calibrated) and developed/trained on/implemented operational procedures for ovens and CNC machines.
Manufacturing/Cleaning Validation Engineer
Carefusion
El Paso, Texas
08.2011 - 12.2012
- Designed a system (Equipment Design Process Evaluation, Product/Equipment Train, and Matrix) to optimize cleaning validation for ChloraPrep Solution
- Developed and implemented work instructions (Operation, Maintenance, Calibration) for various equipment, including Walking Chambers and Environmental Monitoring Systems
- Supported software validation for the REES Scientific Environmental Monitoring System, involving User Requirements, Traceability Matrix, and facility-wide implementation.
Validation Engineer
Aveva DDS
Miramar, FL
08.2010 - 05.2011
- Developed, coordinated, and executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to comprehensively validate packaging manufacturing equipment for form/fill/seal punching, pouching, and carton loading of transdermal patches
- Oversaw qualification activities for critical equipment, including Kettle Mixers, vacuum bag sealers, Harro Hofliger 1 and 2 Packaging Lines, and Dierksmeier 1 & 2 Packaging Lines, ensuring thorough testing and compliance
- Streamlined validation processes for a diverse range of packaging equipment, encompassing form/fill/seal punching, pouching, and carton loading systems used in the production of transdermal patch products.
- Prepared traceability matrices to ensure traceability of system components.
- Verified that all systems were functioning according to design parameters through testing and inspection.
Validation/Project Engineer
Azopharma Product Development Group
Hollywood, FL
01.2007 - 04.2010
- Cleanrooms-Isolator/ Prostate cancer vaccine.
Validation Engineer / Project Manager
SRI Surgical Express
Tampa, FL
06.2007 - 01.2008
- Sterilization of Surgical gown, laparoscopic instruments.
Validation Specialist
Boston Scientific
Doral, FL
05.2005 - 05.2007
- Biopsy Forceps- Injection Molding-Gage R&R.
Tool Coordinator / QA Inspector
Bolton Medical Werfen Group/ Medtronic
Sunrise, Fl.
01.2002 - 05.2005
- PTA/PTCA Catheters and Stent-Quality Inspection
Fueler/Ramp
National Jets FBO
Ft Lauderdale, Fl.
01.2002 - 05.2005
- Learjet 35, Cessnas, Gulfstream Fueler and ramp, HAZMAT training.
Industrial Mechanic
Coats North America
Bristol Ct
01.1997 - 12.2000
- Nylon Thread manufacturer for Automotive Industry-Machinery assembly
Quality Control Inspector
Peter Paul’s Hershey Company
Naugatuck Ct
01.1997 - 12.2000
- Almond joy manufacturing and compounding
Manufacturing Inspector
Fibercote Park Aerospace
Waterbury Ct
01.1997 - 01.2000
- Advance Composite Materials/Resin E765,E737 for Aerospace
Education
Bachelor of Science - Mechanical Engineering
Southern Connecticut State University
New Haven, CT01-2001
Associate of Science - Technology, Quality Assurance
Southern Connecticut State University, Naugatuck Valley Technical College
Waterbury, CTSkills
- Executing a remediation strategy in response to an Official Action Indicated (OAI) and addressing 483 observations with corrective actions based on regulatory FDA audits
- Software for Temperature/Thermal Mapping: General Electric (GE), MadgeTech, Kaye Validator 2000, LASCAR, Dickson, Dicksonone and OMEGA
- Enhancement and automation of equipment and processes/ Continuous Improvement Initiatives (Automation)
- Programmable Logic Controller (PLC), Input/Output (I/O), Backup, Human Machine Interface (HMI), Variable Frequency Drive (VFD)
- Software tools: Agile, REES Centron EMS Environmental Monitoring System, AutoCAD, SolidWorks, PDM, Calibration Manager, Microsoft Office, Minitab
- Validation Protocol Development
- Quality Assurance Methodologies (CAPA, deviations, NCR, AQL)
- Root Cause Analysis
- Statistical Analysis and Data Interpretation
- Regulatory Compliance (FDA, ISO, GMP)
- Good Documentation Practices (GDP)
- Cross-Functional Collaboration
- Computer System Validation (CSV)
- Equipment and Process Validation
- Validation Testing and Verification
- Troubleshooting and Problem-Solving
- Communication Skills (Written and Verbal)
- Equipment & Process Validation (eg, Granulation Suite, Filling & Packaging Lines)
- Temperature & Humidity Mapping (Warehouses, Manufacturing)
- Cleaning Validation (Equipment)
- Calibration & Preventive Maintenance (Equipment & Instruments)
- Software Validation (eg, REES Environmental Monitoring System)
- PLC Programming & Automation (Programmable Logic Controllers)
- Project Management Tools (Agile, Microsoft Office)
- Design Software (AutoCAD, SolidWorks)
Accomplishments
- Awarded Associate of the Quarter 4th Quarter 2023 with Bioteknica
- Certified in Consulting 101 and Analytical Test/Method Validation by Bioteknica Validation Group
- Completed FDA Pre-Approval Inspection training
- Award for Excellence in Validation: Recognized for outstanding contributions to validation processes that enhanced efficiency and compliance within a pharmaceutical manufacturing environment.
- Accomplishment in Regulatory Compliance: Led a team that successfully achieved FDA approval for a critical validation project, ensuring adherence to stringent regulatory standards.
- Honors for Innovation in Validation Protocols: Received commendation for developing novel validation protocols that significantly improved product quality and reduced validation cycle times.
- Recognition for Cross-functional Collaboration: Acknowledged for fostering strong partnerships across departments to streamline validation procedures and achieve operational excellence.
Certification
Warning Letter (OAI) Resolution (Engineering & Validation Gaps) New Drug Application (NDA) Changes Process Validation (PV) Protocols & Reports (OTC, Rx Products) Regulatory Audits & Inspections (Documentation & Assistance) Technical Training & Development (Work Instructions, Operations) Mentorship (Engineering Interns)
Languages
English
Professional
Spanish
Professional
Short term rRemediation and Special projects
- Alcon (Novartis)-Freezer Temp Mapping- Duluth, Atlanta
- Actavis (Allergan)-Serialization-Sunrise Florida
- Goodwin Biotechnology-Steam Sterilizer Mapping-Pompano Florida
- Rexal Sundown Naturals-Warehouse Temp Mapping-Miami Florida
- Bioresource Technologies Inc. Lyophilizer Validation-Weston Florida
- Chemo Corporation- Entire Compounding/Filling Packaging Equipment -Miami Florida
References
References available upon request.
Timeline
Quality Engineer
Microvention Terumo
01.2024 - 04.2024
Validation Engineer
Amsino Healthcare
09.2023 - 01.2024
Validation / Engineering Manager
Pure Source
05.2019 - 09.2023
Sr. Validation Engineer Associate
PL Developments
09.2017 - 09.2019
Sr. Validation Engineer
Unipharma LLC
09.2016 - 09.2017
Validation Engineer
Siemens Molecular Diagnostics
03.2016 - 04.2016
Validation Engineer
Actavis-Allergan (TEVA)
02.2016 - 03.2016
Validation Engineer
Abbott Medical Optics (AMO)
10.2014 - 12.2015
Validation Engineer
Promega Corporation
10.2013 - 09.2014
Validation Engineer
Zimmer Biomet Dental
01.2013 - 08.2013
Manufacturing/Cleaning Validation Engineer
Carefusion
08.2011 - 12.2012
Validation Engineer
Aveva DDS
08.2010 - 05.2011
Validation Engineer / Project Manager
SRI Surgical Express
06.2007 - 01.2008
Validation/Project Engineer
Azopharma Product Development Group
01.2007 - 04.2010
Validation Specialist
Boston Scientific
05.2005 - 05.2007
Tool Coordinator / QA Inspector
Bolton Medical Werfen Group/ Medtronic
01.2002 - 05.2005
Fueler/Ramp
National Jets FBO
01.2002 - 05.2005
Industrial Mechanic
Coats North America
01.1997 - 12.2000
Quality Control Inspector
Peter Paul’s Hershey Company
01.1997 - 12.2000
Manufacturing Inspector
Fibercote Park Aerospace
01.1997 - 01.2000
Bachelor of Science - Mechanical Engineering
Southern Connecticut State University
Associate of Science - Technology, Quality Assurance
Southern Connecticut State University, Naugatuck Valley Technical College
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