Engineer Process
Resume:
Dr. Julie S. Suk
Greer, SC 29650
**********@*****.***
Education: B.S., Bioengineering, University of Pennsylvania, Philadelphia,
PA
M.S., Chemical Engineering, Columbia University, NY, NY
D.E.S., Chemical Engineering, Columbia University, NY, NY
Summary of Experience:
Twenty three years experience as a process engineer in chemical and
biotech industries. At Roche Carolina, managed capital projects upto
$550K, writing studies, requests for capital, and steering projects from
conception to validation. At Amylin, wrote FRS's and performed
commissioning of software. At SWPF, created HMI's. At Amgen, performed
shake down runs. At MedImmune Vaccines, provided technical leadership to
support the manufacturing programs, preparation of regulatory
submissions, writing specifications, updating drawings, coordinating
installation, calibration and validation of new systems. At Fluor,
designed processes, equipment and validation for fermentation and
purification of proteins derived by rDNA technologies. Research
experience in fermentation and modeling of cellular metabolism. In-depth
knowledge in a wide range of manufacturing processes, from bulk commodity
products including polyethylene and monosodium glutamate to novel
pharmaceuticals.
Specific Experience
Wood Group Mustang (2012 - Present)
Biotech Consultant
. Eastman Chemical Company. Performing relief calculations.
. Roche Carolina, Florence, SC. Execute capital projects ranging up to
$550K. Included were projects ranging from valve replacements,
purified water loop modifications, to CIP skids, to process
modifications. Duties included writing requests for capital
expenditures, creating Issued for Construction packages to contractors
and assisting with qualification and validation efforts.
Parsons (2007 - 2012)
Principal Engineer
. Saltwater Processing Facility, Aiken, SC. For removal of radioactive
waste from nuclear weapons manufacturing facility, writing
Instrumentation Specifications, maintaining database for alarms and
interlocks, creating HMI's in Delta V.
. Amylin, Pharmaceutical Manufacturing, Hamilton, OH. As part of
commissioning team. wrote Functional Requirement Specifications for
automation systems, performed Factory Acceptance Tests and
Instrumentation/Automation Checkouts for a sterile, explosion proof,
formulation, filtration, drying operations, using PLC's.
. Wyeth, Pharmaceutical Manufacturing Plan Upgrades, Andover, MA.
Designed upgrade of cell culture and harvest systems to increase
sterility and increase capacity. Design new process equipment,
relocation of existing equipment and modifications/additions to
automation functionality.
Fluor (2006 - 2007)
Senior Process / Specialty Engineer
. Bristol Myers-Squibb, Large Scale Cell Culture Project, Devens, MA.
Based on 3 products/processes, produced process flow diagrams, mass
balances for purification; Designed Waste Buffer collection system to
collect waste with high BOD for offsite disposal. Completed
Instrument Data Sheets, performed relief calculations, simulated
hydraulics of WFI loops based on different usages.
. Borouge 2 Project, Abu Dhabi, UAE, Middle East. This project
consisted of the front end design for an olefins production plant.
Responsibilities included development of equipment specifications and
effluent summaries for environmental permits.
Amgen (2004 - 2005)
Process Development Consultant
. For the startup of BioNext facility in Rhode Island, performed studies
on tank mixing, sampling and column packing. Involved in shake down
and validation runs. Involved in data mining of In-Process-Controls
and Process Control Parameters for the shake down runs, including cell
culture and purification to ensure compliance with process acceptance
criteria, using Delta V historian.
Fluor, South San Francisco, CA (2002 - 2002)
Process Specialist
. Genentech, South San Francisco, CA. Modified an existing facility to
make Enbrel, including design and installation of new microfiltration
unit and media hold tanks. Installation was performed without
interfering with on going manufacturing.
. VaxGen, South San Francisco, CA. Designed downstream processing for
AIDSVAX, with flexibility to also perform as a contract manufacturing
facility for monoclonal antibodies. Vertical design used minimal foot
print and gravity drain from buffer prep to hold to purification.
Responsible for PFD's, process descriptions, P&ID's, data sheets,
hydraulics calculations and utilities summary.
MedImmune Vaccines, Santa Clara, CA (1999 - 2002)
Process Engineer
. Led multi-task teams in identifying, planning and executing projects
from inception to validations. Duties varied as needed from problem
solving, identifying needs, obtaining consensus from competing
departments, reviewing contracts, supervising construction and
starting up. Provided technical support on new product development
through IND filings.
Fluor, South San Francisco, CA (1997 - 1998)
Process Engineer
. Amgen, Thousand Oaks, CA. Responsible for a pharmaceutical plant
front end design. Calculated utility demand for building 6, a multi
product facility, using different production scenarios. upgraded RO
system, glycol chillers and tower water.
. Baxter-Healthcare, Glendale, CA. Designed and verified procedures for
cleaning validation, testing for trace residues of cleaning material
and product carry over. Efforts involved selection of assay,
validation of assays, writing protocols for various types of equipment
such as ultrafilters, centrifuges, freeze dryer and assisting in the
execution of the protocols.
Clark, Richardson & Biskup, Cary, NC (1995 - 1997)
Process Engineer
. Worked with a variety of small and medium sized clients, producing
detailed design packages including process descriptions, batch
schedules, mass balances, P&ID's, equipment requisition packages,
SOP's for manufacturing, CIP, SIP and integrity testing processes.
Provided basic process designs, equipment selections, evaluations of
vendor equipments, installation, start-up, and warranty
demonstrations.
Fluor, Greenville, SC (1987 - 1995)
Process Engineer
. Lysine Plant, AECI, South Africa, Africa. Responsible for designing a
Lysine (10,000 tons per year) production facility. Produced equipment
list, equipment data sheets and P&ID's for purification.
. Amgen, Thousand Oaks, CA, USA. Responsible for the purification
portion of a multi-product facility to produce monoclonal antibodies
and recombinant therapeutic proteins. Developed PFD's, P&ID's,
process descriptions, data sheets and prepared equipment layout
arrangements.
. Monosodium Glutamate, Ajinomoto, Eddyville, IA. Involved in the
design of a bulk amino acid facility. Responsible for product
purification, including crystallization, centrifugation, and fluid bed
drying design. Developed P&ID's, and equipment data sheets
incorporating a minimal cost approach.
. Betaseron, Chiron, Puerto Rico, Caribbean. Responsible for the
modification of an existing facility to make Betaseron. Project was
driven by schedule due to the unmet demand in the marketplace.
Responsible for the purification train. Developed PFD's, P&ID's,
process descriptions, and turnover packages for validation.
. Lake Center Facility, Synergen, Boulder, CO. Responsible for the
design of the purification portion of a therapeutic protein facility.
The purification section included a multi-functional buffer
preparation area, a state-of-the-art fully automated buffer hold area,
and several two meter diameter chromatography columns which
incorporated CIP, SIP, and sanitary design features. Utilized AutoCad
to draw P&ID's, eliminating errors and resulting in quick turn around,
resulting in an aggressive construction schedule of 18 months from
start of engineering.
. Inter Leukin-2 Facility, Hoffmann-La Roche, Nutley, NJ. Process
Engineer developed validation protocols (Installation Qualification
and Operational Qualification) for the manufacture of a human
therapeutic protein, including media preparation, chromatography,
class 100 bio-safety hoods, and scrubber systems.
. Biotechnology Center, Hoffmann-La Roche, Nutley, NJ. Responsible for
the design of a pilot plant facility to produce monoclonal antibodies
and recombinant therapeutic proteins. Facility design included a
continuous tissue culture bioreactor, cell harvest, and analytical
laboratories. Developed process flow diagrams and piping and
instrumentation diagrams, and prepared equipment layout arrangements.
Utilized PDS to design P&ID's which produced smart drawings.
. Erythropoetin, Ortho Pharmaceutical Manufacturing Facility, Manati,
Puerto Rico, Caribbean. Process Engineer involved in the design of a
biotech facility to produce a therapeutic protein, utilizing
recombinant mammalian cell technology. Key unit operations included a
stirred-tank bioreactor, ultra filtration, and chromatography.
Developed process flow diagrams, material and energy balances, batch
schedules, piping and instrumentation diagrams, and equipment design
specifications. Design incorporated cGMP requirements and NIH
regulations for biological containment.
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