Engineer Chemical Engineering

Patrick Vo

*** ********** **** 610-***-**** (cell)

Lititz, PA 17543 ***********@***.***

Experience with technical transfers involving cross-functional, cross-geography, and cross-company teams.

Experience in pharmaceutical/biopharmaceutical industry, including technical transfer, commissioning, qualification and validation of equipment, process and facility utility systems.

Engineering and Scientific Professional with years of hands-on experience in Validation of facility, process/equipment; formulation development, scale-up; technical transfer and product launch in FDA regulated Medical and Pharmaceutical environments. Prepare Standard Operating Procedures, Project KPI, CAPA, and other procedures. Have working knowledge and understanding of solid/liquid dose pharmaceutical production processes,

Well-developed communication skills, both verbal and written. Owner of six approved patents (refer to attached patent list), Good communication skills. Knowledge and experience in FDA regulated Pharmaceutical operations, electronic batch records & releases, controls & instrumentation automation.

EDUCATION

BS, Chemical Engineering – University of Maryland, College Park, MD

PROFESSIONAL WORK HISTORY

Manufacturing Science &Technology Engineer 02/2018 – Present

Alcon Ophthalmic Pharmaceuticals & Surgical Precision Device – Sinking Spring, PA

Plan and execute Qualification/Validation projects as Technical Lead.

Develop process, equipment, sizing and selection, URS, drawings and instrumentation.

Subject Matter Expert (SME) for process equipment (Eye Surgical Needles, Forceps, Fiber Optics).

Lead task force in the planning, documentation and execution of investigational runs. Interpret study results with recommendations.

Staff Engineer/Scientist 12/2014 – 02/2018

Johnson and Johnson company – Lancaster, PA

Plan and execute Pharmaceutical Validation Engineering projects as Technical Lead, Documentation.

Responsible for the Commissioning and Qualification (C&Q) process.

Creates, routes for approval, and implements any documentation relevant to installation, qualification, and or validation of equipment, cleaning, automation and process validation.

Provides expertise and guidance on all processes, procedures, functions, regulations and documentation associated with the IQ/OQ/PQ.

Directly oversees any Technical Operations Subject Matter Experts (SMEs).

Process Technology Lead Scientist 1/93 – 11/2014

Bayer AG – Morristown, New Jersey and Myerstown, PA

Plan and execute Production Validation projects related to consumer care manufacturing to develop or improve facility, products, and MES processes.

Possess in-depth understanding as well as hands-on experience in product development.

Independently conceived and conducted research, organized and analyzed results and presented findings.

Provided solutions to a wide range of difficult problems through creative problem-solving.

Expertise in development of new methods, technologies, and processes to promote project advancement.

Generated more than 1,000 validation/development documents of value to the company.

Served as a leader and contributing member on more than 50 project teams (Mycelex Cream, Neo-Synephrine Nasal Spray & Drop, Ambien, Cipro, 81 mg Aspirin, One-A-Day Vitamins, Aleve, Aleve PM, API, etc.).

Represented department in multi-disciplinary projects as a technical expert and/or project leader.

Pharmaceutical Project Engineer 3/91 –1/93

Bristol-Myers/Squibb Co., Central Engineering Division, Syracuse, NY

Products included Liquid Sterile filling system, freeze drying system via sublimation process (freeze and vacuum), super-heated water autoclave at terminal sterile fill.

Conducted initial feasibility studies and risk assessments with a primary focus in the aseptic fill/finish area.

Participate in the development of concepts and specifications, design and fabrication, commissioning and qualification of process equipment systems in a GMP environment.

Managed project budgets ($1MM).

Served as process specialist on several multi-functional project teams.

Interfaced closely with manufacturing during process transfer and validation.

Designed, modified and expanded existing production capacity (Humacao, Mayaguez, PR).

Coordinated activities and information exchange for numerous project teams.

Other Experience:

Pharmavite Corp. (Maker of “Nature Made” Vitamins), San Fernando, CA

Technical Operations Supervisor

Syntex USA (Roche), Palo Alto, CA

Active Pharmaceutical Ingredient - Product Development Scientist

C.R. Bard, Murray Hill, NJ

Quality Assurance Engineer

US PATENTS HELD – No. / Title / Approved Date

U.S. Patent No. 6224911

Process for the preparation of enteric coated pharmaceutical dosage forms – 2001/05/01

U.S. Patent No. 5942034

Apparatus for the gelatin coating of medicaments – 1999/08/24

U.S. Patent No. 6258400

Process and apparatus for holding medicaments to be coated – 2001/07/10

U.S. Patent No. 6195911

Process and apparatus for drying a plurality of dip-coated medicaments – 2001/03/06

U.S. Patent No. 6132159

Process and apparatus for reorienting medicaments to be coated – 2000/10/17

U.S. Patent No. 6126987

Process for the gelatin coating of medicaments – 2000/10/03

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