Dylan Pham Email & Phone Number

Raleigh, Nc, Us

Cary, North Carolina, United States

- Calibrated 20 Eppendorf Bioflow 120 bioreactors, following cGMP compliance in temperature, pH, DO, and agitation systems- Calibrated 80 mass flow controllers and bioprocessing equipment, optimizing process control- Conducted preventive maintenance and functional testing of bioreactors, autoclaves, and critical systems.- Maintained precise calibration and maintenance records in Indysoft, ensuring full compliance with regulatory and audit standards- Commissioned and validated LIVES International and Kaye ValProbe RT systems for thermal validation and temperature mapping- Calibrated 116 instruments on Sartorius stedim bioreactors, utility panels, freezers, washers, and wastewater skids- Authored 6 SOPs to streamline asset management, maintenance schedules, and GMP compliance- Provided technical support to ensure bioreactor systems met client specifications and operational needs- Ensured compliance with GMP, safety, and PPE standards, maintaining a contamination-free lab environment- Authored and executed the Installation and Operational Qualification (IOQ) for packaging line equipment, ensuring GMP compliance and alignment with design specifications for OTC production across varied product configurations.- Led qualification efforts for key components, including Aesus and Balpack systems, and conducted final product compliance checks to verify weight, labeling accuracy, and packaging integrity.- Developed and authored key Computer System Validation (CSV) documents, including a Project Validation Plan (PVP), Functional Specification (FS), traceability matrix, and Operational Performance Qualification (OPQ) for the TraceableLive Environmental Monitoring System, ensuring compliance with cGMP guidelines.- Led OPQ execution across critical test cases, verifying web interface functionality, data integrity, security, and regulatory compliance while collaborating with clients to address technical inquiries and provide project updates.

North Carolina, United States

-Performed calibrations on 116 measurement instruments on 5 intermediate-scale Sartorius stedim 30-l bioreactors, 2 large-scale Sartorius stedim 30-l bioreactors, utility panels, cryogenic freezers, washers, and wastewater treatment skids-Commissioned and process validated a LIVES International Real-time Data Logger and a Kaye ValProbe RT Thermal Validation system to be used for temperature mapping and thermal validation-Wrote 6 SOP’s for the program to be implemented in a work order system to aid in better alignment with industry GMP standards along with asset management such as equipment recording details such as maintenance schedules and participating in workflows to manage the assets-Exercised operator safety, maintenance, housekeeping practices, quality control, and highly critical importance of PPE

Morrisville, North Carolina, United States

-Drafted validation lifecycle documents including Validation Plans, URS, FMEA Risk Assessments, FRS, Testing Protocols (IOV, IOQ, PQ), Requirements Traceability Matrices, and Summary Reports for Laminar --flow hood and Tulip Manufacturing Execution System-Adhered to FDA regulations including 21 CFR Parts 11, 210, and 211-Reviewed and applied ASTM, ICH, ISA, ISO, ISPE, PDA, PIC/S, and USP guidance and principles-Led project meetings and provided attendees with a summary of discussed topics and action items-Prepared meeting agendas for project discussion-Created and gave a presentation applying the principles of the validation Lifecycle Approach to the process of preparing clean water from an RO/DI skid-Performed temperature mapping of a TCU using a Kaye Validator AVS-Attained OSHA 10 Certification-Took part in professional developmental activities including public speaking workshops

Morrisville, North Carolina, United States

-Conducted research with professional biomedical engineers about modifying DNA to produce pure green fluorescent protein-Operated biotechnology lab equipment to learn about different synthetization and manipulation techniques-Developed a research paper and synthesized the information into a poster to present at the program’s symposium

Bachelor Of Engineering - Be, Chemical Engineering

Activities and Societies: Goodnight Scholar International Society for Pharmaceutical Engineering (ISPE) American Institute of Chemical.

High School Diploma

Activities and Societies: FIRST Robotics State Championship (2016-2020) Junior Marshall (2019) National Honor Society (2018-2020) National.