PROFESSIONAL EXPERIENCE

Background & Expertise

August 2021 - July 2022

Validation Technitian

Bright Future Pharmaceutical Lab. Ltd.

Preforms process validation, cleaning validation, and transportation validation that fulfills GMP requirements, and composing reports as requited.
Preparation of documents required for Department of Health or Food and Drug Administration inspection

May 2024 - Current

Junior Engineer

CTK Bio Canada

Assist in running daily production automation.
Troubleshoot and resolve mechanical failure issues in various machinery.
Identify root causes of recurring machinery failures and implement solutions.
·Identify process bottlenecks and develop strategies to increase throughput.
Optimize production processes for new R&D formulations.
Support senior technicians with routine maintenance tasks.
Perform scale-up and process optimization to enhance operational efficiency.

Bright Future Pharmaceutical

Bright Future is one of the leading pharmaceutical companies in Hong Kong. Their business covers the entire pharmaceutical supply chain from R&D and large scale production to sales and distribution. They provide affordable healthcare solutions with uncompromising quality to improve the quality of life for patients across the world.

Vlidation Technician

Job Overview

Cleaning Validation (CV)

When changes occur in any process engineering steps, it is essential to ensure that the corresponding cleaning Standard Operating Procedure (SOP) is validated to confirm the ongoing effectiveness of the cleaning methods. This validation process ensures that both chemical and microbial residues are reduced to levels within acceptable ranges in accordance with FDA requirements.

Transportation Validation (TV)

After the drugs are produced, they require transportation. Since most drugs are sensitive to environmental factors like light, temperature, and humidity, transportation validation is conducted to provide evidence that each unique transportation vehicle, route, and season maintains a predictable ambient environment and does not compromise the drug's quality.

Process validation (PV)

When critical process engineering steps undergo changes, it is necessary to conduct process validation to ensure that the critical attributes of the produced drugs, such as API dosage, friability, bioavailability, mass, and others, remain within acceptable standard deviation limits. This involves a series of sampling processes to gather and generate evidence that the new production process is reliable.

Quality Assurance (QA)

Quality assurance in pharmaceutical manufacturing, guided by Good Manufacturing Practices (GMP), is essential for the consistent production of safe and effective products. This includes processes like CV, PV, TV, all aimed at upholding product integrity throughout the manufacturing and distribution phases. These validations are critical in ensuring compliance with GMP regulations and fostering trust in the pharmaceutical industry's commitment to delivering reliable medications to patients.

•Assist in running daily production automation. •Troubleshoot and resolve mechanical failure issues in various machinery. •Identify root causes of recurring machinery failures and implement solutions. •Identify process bottlenecks and develop strategies to increase throughput. •Optimize production processes for new R&D formulations. •Support senior technicians with routine maintenance tasks. •Perform scale-up and process optimization to enhance operational efficiency.

CTK Bio Canada

Experienced in biodegradable resin production and customization for diverse customer requirements. Committed to transforming the plastic industry towards sustainability.

Innovative

Constantly exploring new solutions and technologies to enhance product quality and environmental impact. Passionate about creating a greener future.

Customer-Focused

Dedicated to understanding and meeting each customer's unique needs. Striving to deliver tailored solutions that exceed expectations and drive positive change.

Sustainability Advocate

Advocating for sustainable practices and eco-friendly initiatives within the industry. Committed to promoting a circular economy and reducing environmental footprint.

Junior Engineer

Job Overview

Production

Oversee daily production activities to ensure smooth operations, accurately record and analyze production data, and perform troubleshooting to identify and resolve any issues that arise during the manufacturing process.

Process Optimization

Optimize production process parameters during the development of new R&D products by conducting trials and data analysis. Proactively identify potential operational bottlenecks and develop effective strategies to resolve them, ensuring smooth scale-up and efficient integration into full-scale manufacturing.

Maintainence

Maintain all production machinery, including extruders, mixers, gravimetric feeders, vacuum conveyors, and related equipment, by performing routine inspections, preventive maintenance, and minor repairs to ensure optimal performance and minimize downtime.

ERP

Manage and utilize the ERP system to monitor and coordinate production workflows, including material inventory tracking, production scheduling, and work order processing. Ensure accurate data entry and reporting to support real-time decision-making, and collaborate with cross-functional teams to resolve discrepancies and improve system efficiency.