Tuan Ha

Phone: 408-***-****

Email: ad4ful@r.postjobfree.com

Home Address: *** ******** **, *** ****, CA 95116

Professional Profile

I have over 26 years of experience in the Medical Device and Biotechnology industries with a background in Engineering, Lean Manufacturing, Continuous Improvement, and Quality Systems. My expertise is in Lean Manufacturing, Equipment Validation, Cleaning Validation, and Sterilization Validation. Experienced in write and execute protocols, Manufacturing Procedures (MP), and Standard Operating Procedures (SOP). Familiar with commonly used manufacturing equipment including Incubators, Coldroom, Warehouse, LN2, Freezers, Fermenter, Autoclaves, Kaye Validator, Columns, Pumps and Pressure Vessels.

Technical and business skills include:

Risk Assessments

Aseptic Filling

Equipment/Facility/Aseptic Validation

Engineering Validation

SOP generation

(IO, OQ, PQ)

Professional Experience

Grifols Diagnostic Solution Inc. – Emeryvile, CA 07/19-02/24

Validation Engineering I

•Periodic autoclave and fermenter SIP requalification, troubleshooted and resolved issues quickly for fermenter SIP requals.

•Support qualification and startup of Pilot Plant facility/equipment/utilities.

•Support qualification and startup of CMF Phase II facility/equipment/utilities.

•Daily support for cleaning verification and routing monitoring cleaning for fermenter and portable tank.

•Performed periodic requalification activities for various pieces of equipment (steam sterilizers, fermenters) and CMF facility (EM RQ).

•Write and execute protocol cycle development and performance qualification autoclave for CDMO product.

•Authored several memos for adding / modifying qualified items for CMF autoclaves.

•Worked with contractors to revise MVPs related to TCU / coldroom / etc qualifications / requalifications.

•SME with temperature mapping and Kaye Validator AVS system to manage and support multiple validation projects.

•Chamber mapping freezers, refrigerators, incubators, ovens, tanks, autoclave, induction heater, cold room, warm room and warehouse.

•Support for resolution of FDA audit comment concerning supporting documentation for transporting of materials.

•Write and execute shipping test plan for CDMO product.

Baxter Healthcare & Lonza – Hayward, CA 05/08-07/19

Validation Engineering II

•Provide Quality/Validation engineering support to the production and development of medical device and biopharmaceutical products.

•SME of cleaning and sterilization validation for community of practice.

•Assisted in the identification and procurement of new equipment.

•Write and execute validation protocols (IO, OQ, PQ).

•Write and execute commissioning and qualification (C&Q) protocol.

•Worked with Product Development and Manufacturing departments to create equipment and process user requirements.

•Involved in gathering information and requirements for CIP (Clean in Place) protocol development for cleaning validation cycle.

•Experience with cleaning performance qualification for media tank, buffer tank, coupling apparatus and ultrafiltration/diafiltration system.

•Experience with temperature mapping and Kayes Validator 2000 system to manage and support multiple validation projects.

•Chamber mapping freezers, refrigerators, incubators, ovens, tanks, autoclave, induction heater, cold room and warm room.

•Reduce manufacturing costs by developing and executing optimization process studies.

•Wrote and modified MPs and SOPs.

•Coordinated complaint investigations and evaluations on post market products.

Aradigm & Novo Nordisk (Delivery Technology) – Hayward, CA 09/00-02/08

Compounding Chemist Specialist & PMD Team Lead

•Accurate and execution of validation deliverables including /IQ/OQ/PQ protocols and reports for Form Fill Seal

•Participate in Aseptic Process Validation by validate sterile filtration and aseptic filling process with media fills

•Determines and assist in developing methods and procedures to control or modify the manufacturing process.

•Responsible for in-process product testing (pH, Conductivity, TOC & TA Testing) and product qualification during production processing, utilizing unique skills in aseptic technique, state-of-the-art cleanroom practices (as needed) DEA, FDA and GMP.

•Support engineer investigate and identify the problem to suggest process improvement provided consistently high yields and quality.

•Support QC performed P2 Device Testing to release clinical Insulin phase II and III trails.

•Experience with CIP, Swabbing and SIP of Insulin tank.

•Attended many hours of training seminar on Cleanroom Behavior and Gowning for Aseptic Processing.

•Direct supervision or management of manufacturing staff in pre-clinical, clinical, commercial dosage form and device manufacturing.

•Provides direction and leadership to direct reports including scheduling and workload prioritization.

•Interfaces with relevant departments to proactively identify potential issues and develops solutions to minimal supervision to achieve goals.

•Monitors errors and improves documentation accuracy by training and strict compliance.

•Coordinate formulation schedule. Interact with QA, Planner, and Material Handler to obtain necessary documents, raw materials for production.

•Participate in cLean project and training to implement change manufacturing structure became more productive.

•Reviews, Edit, Critique manufacturing procedure such as (SOPs, MBRs & Protocol) and verifies accuracy, implementing approved documentation and/or procedural changes.

•Proficient in MS-Word, MS-Excel, MS-PowerPoint, data analysis and presentation.

Other Skills:

General: Titration, Spectrophotometer, pH, Osmolatity, Conductivity, TOC, Kayes Validator 2000, Kayes Validator AVS

Applications: MS-Word, MS-Excel, MS-PowerPoint

Reference:

Available upon request.

Education

Bachelor of Clinical Science and Minor Chemistry: San Francisco State University, CA (WIP)

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