Medical Device Manufacturing

Virginia Milla

********@*****.***

Newark, CA ***60 510-***-****

Manufacturing Professional

Over sixteen years experience in the medical device/pharmaceutical industry. Extensive experience in aseptic processing of a dermal implant product. Highly skilled in formulating buffer solutions including the operation and troubleshooting of aseptic processing equipment

Knowledge of FDA and cGMP

Knowledge of ISO Standards

Prepare equipment used in Aseptic process

Ability to function in a controlled environment regulated by FDA cGMP

Skilled in Standard Operation Procedures

Quick to comprehend new procedures and technology

Knowledge of weighing and measuring materials and pH solutions

Ability to coordinate and synchronize multiple projects

Professional Experience

ForSight V5, Menlo Park Mar 2015 – Sep 2017

Medical Device Assembler

Building eye care products called “inserts”, a new pharmaceutical drug delivery device used for glaucoma treatment. Processes include:

Suture Thermoforming:

-measuring and cutting suture rings to different sizes

-thermoforming suture rings by using forced air oven

Drug and Non-drug Segment Molding:

-setting tools, equipment for molding: press, analytical balance, chiller, thermometer, bench scale ….

-cleaning mold and loading molding mandrels onto mold

-injecting drug/ non-drug mixture into mold

-curing drug/ non-drug mixture at different conditions (time, pressure, temperature)

-demolding and inspecting molded segments

Ocular inert Assembly:

-loading drug/ non-drug segments onto suture ring

-welding suture rings by using soldering iron or ultrasonic welder

-performing tensile test and diameter checking

-segment orientation on suture ring

-final inspection

-prep ocular inserts for washing

Labeling and Pouching ocular inserts for both drug and non-drug products

-checking and applying labels on pouches

-setting sealer with various programs for pouching: sealing only, sealing with

Vacuum,

-preparing pre- and post- pouch samples for pouch pull test

-performing pouch pull test using Instron, Machenism testers

Packaging for irradiation:

-checking and preparing samples for irradiation

-reconciling samples for post irradiation

Cleaning parts and materials for productions

-cleaning and drying packaging trays, holders, holder bracket, washing basins….

-using Speed Mixer (Flack tek) to clean cups and caps for Drug Mixing Process.

Good practice of documentation, GMP, QSR and FDA regulations

Building samples for R&D projects

Temperature and Humidity Monitoring for CER and Lab equipment such as incubators, lab refrigerators, lab freezers, dry boxes….

-daily, weekly and monthly checking

-downloading data and writing reports

Drug Mixing:

-setting up for drug mixing process (equipment, drug materials, solvents,

-using Speed Mixer (Flack tek) for running drug mixing cycles

-loading mixed drug and preparing drug for molding

Zyomyx, Fremont, CA Jul 2011 – June 2014

Medical Device Assembler

Performed assembly of small parts in a clean room GMP environment

Performed surface treatment of parts including vacuum plasma and a fluid surface treatment processes

Performed in process inspection of sub-assemblies under 10x magnification microscope for surface scratches, alignment of parts, and particulates

Performed final assembly inspection for gross defects, proper labeling, and missing components.

Performed analytical testing: pH, Density and Osmolality for the prepared buffers

Prepared buffers using single channel and multi-channel pipets.

Performed precise secondary operations on parts under microscope.

Performed training of manufacturing processes to new hires.

Responsible for line clearance

Performed documentation and inventory checks

Document manufacturing and inspection activities in accordance with company procedures

Thorough understanding of GMP and ISO standards requirements in manufacturing and quality control

Collaborated with Manufacturing Engineering to provide input for the development of fixtures and tooling to aid in assembly processes

Collaborated with Processes Engineers to develop and improve flow of manufacturing documents (ie. Manufacturing procedures, batch records)

Allergan Medical Corporation, CA 1993-Oct 2008

Clean Room Manufacturing Technician

Performed maintenance of an aseptic environment by sanitizing equipment and clean room surfaces and preparing samples for QC testing.

Worked with following processes: homogenization, mixing, traying, lyophilization and remoisturization.

Cleaned, assembled, wrapped and autoclaved equipment and materials as needed for the clean room operations.

Obtained timely resolutions on quality, safety and efficiency issues.

Assembled, inspected and tested integrity of test equipment and filters per schedule.

Prepared and sterile filtered product buffers and solutions, including weighing and measuring material and pH solutions.

Assembled, tested and operated homogenate and filling line within a clean room environment.

Performed Bulk Room CIP/SIP, CIS sterile filtration, precipitation and cross-linking of zygen.

Operated and monitored computer control panel equipment.

Enforced rules, regulation and safety procedures.

Ensured safe working environments.

Education

Angeles University, Junior Secretarial

Skills

Procedures:

-Safety

-MSDS (Material Safety Data Sheet)

-GMP (Good Manufacturing Process)

-ISO (International Standard Organization)

-Troubleshooting

-Buffer

-WI (Work Instructions)

Machine Operation:

-Syringe TL Filler

-Homog System

-Electronic Weight Scale

-pH Probe

-Buffer Mixer

-Beckman Centrifuge

Technical:

-MS Word

-Internet Research

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