Nicolas Morales-Gagnon
Cary,United States
Summary
Accomplished Validation Engineer at PharmEng Technology with an interest in pursuing Computer System Validation opportunities. Successfully enhanced QC systems' reliability through rigorous validation protocols and cross-functional collaboration. Proficient in IQ/OQ generation and execution, demonstrating strong analytical skills and a commitment to operational excellence.
Overview
2
2
Languages
1
1
Certification
6
6
years of professional experience
Work History
Validation Engineer
PharmEng Technology
Cary, NC
11.2021 - Current
- Developed and executed comprehensive validation protocols for equipment and software (IQ/OQ/PQ).
- Executed equipment qualification activities for utility (clean black) and QC systems (spectrometers, particle analyzers).
- Familiar with computer system validation for GAMP Category 3 (COTS) and Category 5 applications.
- Performed temperature mapping studies for controlled temperature units using Kaye Validator AVS and XpertLog Lives.
- Provided technical support in developing user requirement specifications, validation plans, system descriptions, and SOPs.
- Collaborated with cross-functional teams as project lead while training junior staff on validation best practices.
CQV Engineer / Document Control Specialist
Jacobs Engineering Group
Elkton, USA
07.2020 - 11.2021
- Streamlined information transfer between client and subcontractors through RFIs, submittals, and transmittals using commissioning software and databases like EIDA and PIMS.
- Managed care, custody, and control for system turnover of 150+ systems, including WFI, black/clean utilities, process equipment, and facility/HVAC, ensuring compliance with operational standards.
- Edited design qualification requirement traceability matrices (DQRTMs) in compliance with cGMP, GDP, and ISPE guidelines.
Education
Bachelor of Science - Chemical Engineering
North Carolina State University
Raleigh, NC05-2020
Skills
- GxP
- C&Q
- Equipment Qualification
- Computerized System Validation
- Quality Control Instrumentation
- GAMP Category 3 & 5
- Temperature Mapping
- ValGenesis VLMS
- Veeva
- Kneat Basic User
Publications
Photodynamic Coatings on Polymer Microfibers for Pathogen Inactivation: Effects of Application Method and Composition, Bharadwaja S. T. Peddinti, Nicolas Morales-Gagnon, Behnam Pourdeyhimi, Frank Scholle, Richard J. Spontak, Reza A. Ghiladi, ACS Applied Materials & Interfaces, 2021, 13, 1, 155-163, 10.1021/acsami.0c16953
Languages
French
Professional
Spanish
Elementary
Certification
- Lean Six Sigma Yellow Belt
Timeline
Validation Engineer
PharmEng Technology
11.2021 - Current
CQV Engineer / Document Control Specialist
Jacobs Engineering Group
07.2020 - 11.2021
Bachelor of Science - Chemical Engineering
North Carolina State University