Validation Engineer Continuous Improvement

KWAN OH

Buena Park, CA ***** • 714-***-**** • ******@*****.***

SENIOR VALIDATION ENGINEER

Aseptic Process, cGMP Environment, Instrumentation, Equipment Qualification, Planning, and Manufacturing

Accomplished and detail-oriented Validation Engineer with extensive experience in equipment and process qualification in cGMP environments. Hands on and collaborative style team support. Skilled in IQ/OQ/PQ execution, computer system validation, process validation, and aseptic pharmaceutical manufacturing. Strong understanding in test planning, root cause, driving for results and compliance documentation. . Recognized for driving results, ensuring regulatory compliance, and leading cross- functional teams in validation and continuous improvement initiatives. TECHNICAL SKILLS

• Validation & Qualification – Installation, Controller and Operational Qualification (ICOQ), Performance Qualification (PQ), User Requirement Specifications (URS), Design Qualification Requirements (DQR), System Risk Assessment (SRA), Configuration Specification (CS), Release Check List (RC), Functional Design Specification (FDS) and Requirements Risk Assessment (RRA), Requirement Traceability Matrix (RTM) and Validation Summary Report

(VSR).

• Equipment & Systems –Autoclaves, Lyophilizers, Depyrogenation Tunnels, CIP/SIP System, Vial Washers, VHP Isolators, Utility Systems, QC Lab Equipment, Data Acquisition Systems,

• Documentation & Compliance – Protocols, SOPs, Change Controls, Continuous Improvement

• Analytical Methods & Tools – CAPA, Deviation Investigation, Environmental Monitoring, Bioburden & Microbial Testing

• Regulatory & Industry Expertise – cGMP, FDA, ISO, 21 CFR, GAMP 5, Aseptic Processing, Pharmaceutical Manufacturing, Cross-functional Leadership Senior Validation Engineer

Pharmaceutical Services Corporation (PSC) Biotech, Pomona, CA Senior Validation Engineer (Consultant at Gilead Sciences / La Verne, CA 2022 - Present

• Execution and management of qualification for TCUs, tanks, formulation equipment, CIP/SIP systems, other process equipment, process qualification and QC Laboratory Equipment including document generation and revisions.

• Generated and executed protocols: Controller and Operational Qualification (ICOQ), Performance Qualification (PQ), User Requirement Specifications (URS), Design Qualification Requirements

(DQR), System Risk Assessment (SRA), Configuration Specification (CS), Release Check List

(RC), Functional Design Specification (FDS) and Requirements Risk Assessment (RRA), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).

• Qualified Portable Tanks, Steam-In-Place tanks, QC Laboratory Equipment, Data Acquisition Systems, and Single-Use Technology (Mobius Mix Tank).

• Responsible for performing and generating Periodic Reviews (PERs) for validated and/or qualified computerized systems and IT Infrastructure.

• Assisted in the revision of Standard Operating Procedures (SOPs).

• Experienced in the qualification of Computer Software Validation and Process Validation

• Experienced in a cGMP environment for process equipment and manufacturing systems.

• Demonstrated the ability to translate system requirement specifications into executable validation protocols.

• Demonstrated knowledge of pharmaceutical manufacturing of pharmaceutical products, aseptic processing, process development and computer systems validations. Teva Parenteral Medicines, Inc., Irvine, CA

Validation Engineer II, Manufacturing Science & Technology (MS&T) 1994 – 2022

(Sicor Pharmaceuticals acquired by Teva Pharmaceuticals)

• Generated and executed validation protocols (IQOQPQ) and final reports to qualify GMP equipment.

• Qualified and re-qualified sterilizers, depyrogenation tunnels, autoclaves, lyophilizers, CIP/SIP systems, vial washers, isolators, VHP sterilizers, and pure steam systems.

• Performed cleaning and process validation activities for NPI and existing product support.

• Resolved deviations and executed CAPA.

• Authored/reviewed VMPs, Master Batch Records, SOPs, and Change Control documentation.

• Led cross-functional teams (Validation, Engineering, Manufacturing, QC, QA, Metrology, Maintenance).

Telios Pharmaceuticals, San Diego, CA

Microbiologist 1992 – 1994

Implemented environmental monitoring program within the company for controlled clean rooms

• Performed bioburden, growth promotion and microbial identification testing according to USP for water samples

• Executed validation activities relating to aseptic processing, lyophilization and terminal sterilization

• Operated validation and laboratory equipment such as an autoclave, microscope, Kinetic QCL LAL system and KAYE temperature data logger

EDUCATION

North Park College, Chicago, IL B.S., Biology, 1983-1988

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