BRANDON RIVERA
Omaha,NE
Summary
Hands-on Validation Engineer with a proven track record of success in both the medical device and pharmaceutical industry. Skilled in developing and maintaining documentation records, ensuring reliable data to support process validation and quality assurance. Experienced in quality compliance, commissioning, qualification and validation activities, cleaning validation, and engineering. Expert in computerized systems and deeply knowledgeable in regulatory standards, including GAMP5 and CFR Title 21. Committed to upholding high-quality and safety standards to ensure patient safety and meet business needs.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Validation Engineer
Validation & Engineering Group, USA, Inc.
06.2022 - Current
- Generation of Comparability protocol for Moisture Analysis to facilitate the transition from Loss on Drying to Moisture Analyzer methods for in-process thyroid material testing
- Generated R&D protocols on tablet hardness and stability, optimizing product quality and compliance
- IOQ protocol execution and protocol report generation for laboratory expansion, enhancing laboratory capacity
- IOQ protocol execution and protocol report generation for drying oven, HVAC system, and domestic water systems, ensuring compliance and operational efficiency
- Assigned equipment numbers for manufacturing equipment and laboratory instrumentation to enhance tracking and maintenance management
- Generated change controls to ensure continuous compliance and system updates
- Analyzed how temperature, humidity, bottle material and thickness, along with desiccants, impact drug product stability, informing better packaging choices
- Supported a continuous improvement project for manufacturing processes by assisting in the replacement of heptane tanks, enhancing production efficiency and safety
- System impact assessment, IOPQ protocol generation, protocol execution, and protocol report for Water Activity Meter used to determine microbial growth in product and for the acceptance or rejection of product batches
- Developed protocols for the safe decommissioning of manufacturing equipment and laboratory instrumentation, ensuring compliance with safety standards and efficient asset turnover
- Created and managed Periodic Reviews for the Dry Side Manufacturing Area, HVAC systems, Analytical Balances, and Lab Ovens, ensuring ongoing operational compliance and equipment efficiency
- Assisted in developing and implementing remediation plan across quality, manufacturing, and engineering functions in response to an FDA 483 warning letter, enhancing compliance and operation standards
- Lead calibration program, ensuring all facility equipment and instrumentation adhered to regulatory compliance and performance standards
- Managed calibration services with external vendors, ensuring equipment accuracy and compliance, while maintaining strong partnerships for reliable service
- Developed forms such as Calibration Extension Request Form, Missing Calibrated Equipment Form, Out of Tolerance Condition Assessment Form, and Removal of Retirement of Equipment Form to enhance equipment tracking and compliance in engineering operations
- Evaluated CMMS providers to implement a system for managing preventative maintenance and calibrations, enhancing facility operations and equipment reliability
- Created logbooks including Calibration Extension Log Entry, Calibration General Adjustment Log, and Instrument Tracking Logbook to ensure tracking and management of calibration activities and instrument statuses, facilitating enhanced compliance and operational efficiency.
Validation Engineer
Minds for the future program
04.2021 - Current
- Theoretical and hands-on training in validation and engineering processes within the pharmaceutical, biotechnology and medical devices industry
- Training in GAMP5 – Risk Based Approach to compliant GxP Computerized Systems
- CFR Title 21 - Part 4, 11, 117, 210, 211, and 820
- Equipment protocol generation and execution
- Training in International Society for Pharmaceutical Engineering (ISPE)
- Training in Cleaning Validation
- Training in Technical writing
- Training in commissioning, qualification, and validation lifecycle as it relates to regulatory requirements.
Validation Engineer
Validation & Engineering Group, USA, Inc.
04.2021 - 06.2022
- Led the expansion of two new contact lens manufacturing processes, enhancing production capabilities
- Experience with Valgenesis for digitized generation and execution of protocols
- Developed and executed IOQ protocols for contact lens inspection and transfer modules, ensuring system reliability
- Generated IOQ protocol for a contact lens solution dosing module, optimizing dosage accuracy
- Executed IOQ protocol for the relative mold-movement module to ensure precise operational standards in manufacturing
- Generated and executed a Validation Plan, Risk Assessment, Part 11 Assessment, URS, IQ/OQ, and Cleaning Verification for parts washers, ensuring compliance and equipment efficacy
- Execution of protocols for utility systems such as chill water and compressed air to maintain system integrity and operational efficiency.
Education
Bachelor’s in Biology/Pre-Medical -
Skills
- Ability to lead
- Highly dedicated and self-motivated
- Time management
- Attention to detail
- Critical thinking
- Research and statistical analysis
- Present data to stakeholders
- FDA regulations
- Strong technical writing and verbal communication in both English and Spanish
- Expertise in Computer Systems including but not limited to Office 365, VISIO, Adobe, Valgenesis, Master Control, Veeva, among others
- Equipment Qualification
- Data Integrity
Certification
- Developing Critical Thinking Mindset
- Blockchain Basics
- Job Skills: Learning the Basics
- Lean Six Sigma Foundations
- Technical Writing: Quick Start Guides
- Time Management Tips: Following Through
- ACS (American Chemical Society)
- 1st Exhibition of Anatomical Models, School of Natural Science and Technology
Research
- Cellular Molecular Lab Technician, Research project for Bacteria Resistant Genes exposed to different antibiotics from Water Environments: DNA Extraction, PCR, Gene sequencing.
- Electrochemistry Lab Technician, Preparation of microelectrodes and ACF (Artificial Cerebral Fluid).
- Data Verifier, Clinical study with Larkin Community Hospital. “The Tort Test: a novel test to detect failed rotator cuff repairs – a comparison to MRI findings”.
Personal Information
Title: BSA
Volunteer Experience
College of Doctors and Surgeons of Puerto Rico, 08/2020, 12/2020, Recollect and verify statistical data for COVID-19 Molecular and Antigen tests., Inform and organize groups of people for vaccination of Influenza/COVID-19.
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Validation Engineer
Validation & Engineering Group, USA, Inc.
06.2022 - Current
Validation Engineer
Minds for the future program
04.2021 - Current
Validation Engineer
Validation & Engineering Group, USA, Inc.
04.2021 - 06.2022
Bachelor’s in Biology/Pre-Medical -
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