Highlights:ANALYTICAL VALIDATION ENGINEER LOTTE BIOLOGICS U.S.A, LLC 01/2023 - Present EAST SYRACUSE, NY,13208 Bristol Myers Squibb 09/2022 - 12/2022 EAST SYRACUSE, NY,13208 VALIDATION CONSULTANT Genentech 10/2021 - 05/2022 VACAVILLE, CA

Skills:CQV, Commissioning, Data Analysis, IQ/OQ/PQ, URS, SOP, DQ, Final Summary Report, Data Integrity, CSV

Goal:My professional experience includes analyzing the validation requirements include creating and reviewing Validation Plans, protocols, reports, and good documentation practices. I am Interested in opportunities utilizing my skills to ensure product quality and regulatory compliance while contributing to the organization's success and growth. With my educational background and my attention to detail and performance, I am in an excellent position to help your organization to produce top-quality software products.

Membership:MACNY, Society of Professional Engineers

Certification:Assistive Design CertificateCAD and Digital Manufacturing Certified Energy Manager (CEM) Certified Manufacturing Engineer (CMfgE)  Certified Quality Engineer (CQE) Certified Systems Engineering Professional (CSEP) Digital Manufacturing and Design Technology Certification Certified Airframe and Power Plant Mechanic FAA Certified Private Pilot (Single and Multi Engine)

Analytical Validation Engineer 09/2022 - current
Lotte Biologics USA, LLC, SYRACUSE, New York United States
Industry: Pharmacutical Manufacturing
At Lotte Biologics my job roles and responsibilities i had a hands on experience in lab instrument validation, I created URS/FRS, conduct risk assessments, and develop IQ/OQ/PQ protocols. Proficient in CAD for functional layouts, I focused on process improvements and safety. As an SME, I support regulatory inspections, oversee Change Control, and manage supplier quality. In QA oversight, I contribute to GMP manufacturing activities. Implementation of SDLC procedures aligns with FDA guidelines. My skill set includes documentation, safety, quality assurance, compliance, and process optimization
• Authored Computerized and Non-Computerized Lab Instrument validation and qualification documentation including URS/FRS, Risk assessments, DQ protocols, • IQ/OQ/PQ protocols, Traceability Matrix, Configuration Specifications, Validation Summary Report • Utilize CAD drafting techniques (AutoCAD or AutoCAD LT) for designing functional layouts and equipment solutions. • Working on process improvements to bring the process in statistical control. • Ensured a safe working environment during implementation and qualification, recorded and reviewed data using GDP, conducted investigations when necessary, and created/reviewed documentation including IO/OQ/PQ for process equipment, validation protocols, SOPs, pFMEA, and dFMEA. • Served as a Subject-Matter Expert (SME) for data trending and provided manufacturing support during regulatory agency inspections. • Responsible for Change Control activities for Manufacturing Equipment and Instruments • Evaluated change control requests per SOPs, served as a Validation Services designee when needed, managed documentation and database systems, analyzed LIMS enhancements. • Participating in supplier quality reviews and managed product quality matrices such as PPM and other development programs with vendors to ensure products met in-house quality standards. • Facilitate QA oversight of commissioning, qualification, and validation activities to deliver early phase GMP manufacturing facility which includes raw material, Formulation and Drug Product • Implemented the Software Development Life Cycle procedures and conformance to 21 CFR FDA guidelines and Data Integrity regulations. • Conducted weekly production meeting and share information with the production team members about production goal, challenges, safety, and quality. • Knowledge of PMs on Manufacturing Equipment. Worked on time study of manpower and equipment and reduce time lag and increase production output.--
Validation Consultant 10/2021 - 05/2022
Genentech, Vacaville , California United States
Industry: Pharmacutical Manufacturing
At Genentech, I authored URS/FRS, risk assessments, and IQ/OQ/PQ protocols. Proficient in AutoCAD, I design layouts, emphasizing process improvements for statistical control and safety. As an SME, I support regulatory inspections and oversee Change Control, LIMS enhancements, and supplier quality reviews. In QA oversight, I contribute to GMP manufacturing and implement SDLC procedures. Weekly production meetings facilitate communication on goals, challenges, safety, and quality. My expertise includes PM on Manufacturing Equipment and time studies for optimized production.
• Authored Computerized and Non-Computerized Lab Instrument validation and qualification documentation including URS/FRS, Risk assessments, DQ protocols, • IQ/OQ/PQ protocols, Traceability Matrix, Configuration Specifications, Validation Summary Report • Utilize CAD drafting techniques (AutoCAD or AutoCAD LT) for designing functional layouts and equipment solutions. • Working on process improvements to bring the process in statistical control. • Ensured a safe working environment during implementation and qualification, recorded and reviewed data using GDP, conducted investigations when necessary, and created/reviewed documentation including IO/OQ/PQ for process equipment, validation protocols, SOPs, pFMEA, and dFMEA. • Served as a Subject-Matter Expert (SME) for data trending and provided manufacturing support during regulatory agency inspections. • Responsible for Change Control activities for Manufacturing Equipment and Instruments • Evaluated change control requests per SOPs, served as a Validation Services designee when needed, managed documentation and database systems, analyzed LIMS enhancements. • Participating in supplier quality reviews and managed product quality matrices such as PPM and other development programs with vendors to ensure products met in-house quality standards. • Facilitate QA oversight of commissioning, qualification, and validation activities to deliver early phase GMP manufacturing facility which includes raw material, Formulation and Drug Product • Implemented the Software Development Life Cycle procedures and conformance to 21 CFR FDA guidelines and Data Integrity regulations. • Conducted weekly production meeting and share information with the production team members about production goal, challenges, safety, and quality. • Knowledge of PMs on Manufacturing Equipment. Worked on time study of manpower and equipment and reduce time lag and increase production output.--

New Jersey Institute of Technology 07/2018 - 05/2022
Newark, New Jersey, United States
Degree: Bachelor's Degree
Major:Mechanical Engineering Tech
NJIT's ME Program emphasizes hands-on experience and state-of-the-art software in mechanical design, controls, power generation, CAD/CAM, HVAC, and engineering sales. The MET Program offers a comprehensive four-year curriculum, providing a strong foundation in mathematics and science for graduate school or professional engineering licensure. With a minimum of 120 credits required for graduation, it ensures a holistic education in mechanical engineering.

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