Quality Assurance Manufacturing
Resume:
Michael A. Molinario Jr.
West Bridgewater, MA 02379
***********@*****.***
EXPERIENCE
ORGANOGENESIS; Canton, MA
Winter 2006-Spring 2013
Process Engineering Technician I
. Increased Organogenesis's 150 & 275 Dan Rd construction and validation
readiness by decreasing overall project risk and completing equipment
supplies lists, understanding user requirements and verifying items
with the appropriate users. Ordered and received equipment to meet the
project schedule.
. Developed a complete personnel and material flow for a new
manufacturing facility. Worked with user groups to develop agreed
flows for gowning, batch record paperwork, and calibration of
manufacturing equipment. Identified all equipment, supplies, and
furnishings required to populate a new manufacturing facility creating
lists with cut sheets providing all equipment information for every
group under production.
. Developed process parameters for use in production incubator
engineering runs. Assisted in experiment design and carried out
engineering runs. Calculated process timings' and generated a worst-
case scenarios to determine optimal manufacturing conditions based on
product flow. Proved out methods for automating principal product
creation and packaging processes. Conducted trials for both agarose
and cellular feeds developing necessary methods to keep the product 38
and 2-8 degrees Celsius.
. Collaborated with overseas engineering firm responsible for designing
and manufacturing a fully automated production module for use in class
100 lab environments. Created and updated a mock up for several of the
phase 3 automation models. Updated robotic processing station mock up
as needed to match final specifications and identified problem areas.
Learned basic SolidWorks to be able to complete the RPS mock-up and
share the designs with end users to develop a method of setting-up and
breaking down the RPS aseptically providing a written document of the
solution. Acquired drawings and quotes for proposed tubing sets from
several vendors.
. Learned Cell Culture methods for HDF and HEP cells grown in both
adherent and suspension cultures, including cell dissociation,
counting cells, determining optimal seeding density, and preparing new
culture vessels for passaged cells. Worked on developing alternative
methods for harvesting cells in a closed system 10K lab environment.
. Instructed manufacturing personnel on the operation of a class 100
semi-automated processing station about to go into production this
summer, including validation runs and aseptic fills.
Production Associate II
. Manufactured media & processed a living product according to
established MBRs and SOPs under cGMPs within Class 10,000 and Class
100 clean room environments.
. Responsible for keeping a monthly component database of lot numbers
& inventory discards with
additional documentation responsibilities including batch records and
production aids
. Assisted in preventative maintenance of all laboratory equipment,
including calibration and routine maintenance to maintain a high
production output.
. Assisted in the creation and final review of all
documentation paperwork generated by the department.
. Participated in the inception and validation of an automated
processing station for manufacturing, working closely with
engineering/validation, product development, quality assurance, and
facilities.
CHARLELS A. HARRINGTON ASSOCIATES; Chadwicks, NY
Fall 2004-Summer 2005
Clean Sweep Associate
. Performed vendor and merchandise service in Southeastern
Massachusetts Home Depots.
. Created and improved point of purchase displays.
. Participated in store reset of lighting department in less
than a week.
. Trained new employees on vendor services.
UNITED STATES POST OFFICE; East Bridgewater, MA
Summer 2004
Casual Letter Carrier
. Quickly learned and covered postal delivery routes in all
three Bridgewater towns
. Completed mail sorting, setup, and breakdown
. Fulfilled daily operational tasks
EDUCATION
BRIDGEWATER STATE COLLEGE; Bridgewater, MA
Bachelor of Arts in Communication Studies and Research
January 2003 Minor in Physics
Activities
. Lambda Pi Eta, the National Communications Association Honor
Society
. Physics Club
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