PROCESS ENGINEER

FOCUS: DEVELOPMENT & IMPROVEMENT OF PROCESSES | AREA: BIOTECHNOLOGY / PHARMACEUT

ICAL INDUSTRY
QUALIFICATION PROFILE
Highly skilled chemical engineer with 4.5-years process and cleaning validation
experience. Over a year's experience in the design, scale-up, and operation of m
anual and automated filtration equipment. Successfully led multiple projects on
multiple unit operations. Proven ability in leading and supporting cross-functio
nal teams in project execution and process troubleshooting. Strong background in
fermentation and purification equipment, and a SME in chromatography operation.
Highly familiar with historical and current process analysis for identifying pr
ocess parameters and providing requirements for updating current process equipme
nt. Strong knowledge of cGMP principles. Developed hands-on skills with bench-sc
ale protein analysis and cell culture background during research studies. Extrem
ely effective in stressful situations.
EDUCATION
Master of Science in Chemical Engineering, North Carolina State University -Rale
igh, NC: Aug 2003
Bachelor of Science in Chemical Engineering, Virginia Polytechnic Institute & St
ate University -Blacksburg, VA: May 2001 (magna cum laude)
AREAS OF EXPERTISE
* Fermentation & Purification Equipment Knowledge
* Leadership, Time Management & Prioritizing
* SME of Chromatography Operation
* Hardworking & Detail-oriented
* Process Support & Troubleshooting
* Oral & Written Communication
* Equipment Qualification Review & cGMP Knowledge
* Strong Analytical Abilities
* Process Data Analysis
* Micro / Ultrafiltration Process & Equipment Design
* Multi-tasking team player within a fast-paced setting
PROFESSIONAL EXPERIENCE
SMARTFLOW TECHNOLOGIES (FORMERLY NCSRT, INC.) - APEX, NC: SEPT. 2008 - PRESENT
* Initial customer contact in designing appropriate process and equipment for c
ustomer-specific applications, including cell culture harvest or protein separat
ion / concentration.
* Complete and review applicable P&ID drawings for customer requested systems.
* Work with project engineering to define system requirements for customer appl
ications, including URS, FDS, and DDS review.
* Developed and performed bench scale UF and MF testing of varying customer sup
plied starting materials. Prepared technical reports based on in-process data an
alysis from filtration runs.
* Coordinated long term testing plan for NF testing of yeast hydrolysate, inclu
ding documentation and customer support.
* Coordinate with customers for on-site demonstrations, including test developm
ent, equipment design, and coordination with system and filter shop.
* Customer liaison for FAT testing of automated filtration skids. Prepare and p
erform FAT testing.
* Act as technical support on module installation, performance, and qualificati
on for key customers in biotechnology / pharmaceutical industry.
 * Created instruction manual for newly designed filter module.
TALECRIS BIOTHERAPEUTICS - CLAYTON, NC: SEPT. 2005 - SEPT. 2008
VALIDATION SPECIALIST II: JAN. 2008 - SEPT. 2008
* Led cross-functional team to evaluate improvements to current cleaning valida
tion methodology.
* Lead engineer for process revalidation evaluating and identifying critical pr
ocess parameters and quality attributes. Led cross-functional project team to co
mplete characterization testing and validation execution, including schedule / t
imeline development and coordination.
* Lead validation engineer for the qualification and validation of new gel filt
ration column train and liquid chromatography skid. Developed and maintained sch
edule / timeline of validation activities, coordinated activities with engineeri
ng, quality, regulatory, technology, and technical operations.
* Prepared IQ/OQ, CV, PV, and ETP protocols for new gel filtration column train
and liquid chromatography skid, executed IQ protocols for column train and skid
, and assisted in execution of OQ protocols for column train.
* Managed developmental testing and analysis for new gel filtration column trai
n and liquid chromatography skid.
VALIDATION SPECIALIST: OCT 2006-JAN 2008
* Led cleaning validation of two processing tanks.
* Kicked-off implementation of new buffer mixing vessel with identification of
parameters and processing / validation requirements.
* Led process and cleaning validation of spare gel filtration chromatography co
lumn. Planned new process validation quality attribute acceptance criteria based
on current and historical processing capability.
* Wrote and implemented new Chromatography Validation SOP. Performed department
al training for initiation of SOP.
* Prepared investigation reports for executed protocols.
VALIDATION ENGINEER II: SEP 2005-OCT 2006
* Lead validation engineer for process validation and mixing qualification scal
e-up. Coordinated activities, developed mixing acceptance criteria, executed mix
ing qualification, compiled data, and prepared final reports.
* Developed and executed bench scale testing method to determine column buffer
behavior in spectrophotometer and worked with cross-functional team to identify
cause of cleaning validation deviation.
* Cross-functional team lead on investigation involving chromatography percent
recovery deviation. Performed historical and current process review and data col
lection.
* Successfully managed the re-qualification activities on Bulk Pasteurizer as w
ell as the cleaning validation of four processing tanks in Purification area.
WYETH VACCINES -SANFORD, NC: MAR 2004-SEP 2005
VALIDATION ENGINEER II
* Led cross-functional teams to find root causes and corrective actions for pro
cess, cleaning, and equipment validation deviations in fermentation / purificati
on area.
* Designed process requirements for the scale-up of ion exchange chromatography
column including FRS, URS, FAT, packing methodology, and validation criteria.
* Evaluated qualified status of equipment based on maintenance, calibration, pr
ocess parameters, and instrumentation reviews.
* Prepared regulatory submission document with data analysis for release specif
ication change.
* Performed statistical analysis to define new release specifications and in-pr
ocess controls.
* Compiled, organized, and performed statistical comparison of in-process data
to support product hold times.
* Reviewed manufacturing production records to ensure accuracy of process param
eters in fermentation and purification.
OTHER EXPERIENCE
PRIVATE MATH / SCIENCE TUTOR AND SAT PREPARATION TEACHER MASTERMIND PREP -RALEIG
H, NC: 2003-2004
GRADUATE RESEARCH (CHEMICAL ENGINEERING DEPT) NORTH CAROLINA STATE UNIVERSITY -R
ALEIGH, NC: 2002-2003
UNDERGRADUATE RESEARCH (CHEMICAL ENGINEERING DEPT) VIRGINIA TECH -BLACKSBURG, VA
: 1998-2001
Professional Development
Effective Presentation Skills, APLS Group: June 2008
Fundamentals of Project Management, Interactive Consulting Services, Inc.: May 2
008
Fundamentals of Management for Non-Managers, CAI, Inc.: May 2007
Team Based Project Management, Lewis Institute, Inc. in North Carolina State Uni
versity: Apr 2005
Writing Effective Procedures and Technical Report Writing, IWCC Program: Sep 200
4
Engineer-In-Training: Jun 2001
LABORATORY SKILLS
* Process development for new systems: cell implantation in alginate hydrogels,
fluorescent labeling of cells for viability testing in alginate gel, immunoassa
y for verification of protein production in alginate hydrogel, and a vertical di
ffusion chamber system
* SDS-PAGE, DNA gels, Western blots, ion exchange and size exclusion chromatogr
aphy, spectroscopy
* Fluorescent confocal microscopy
* Mammalian cell culture, sterility testing, BCA protein assay, ELISA assay
KEY ACHIEVEMENTS
GAANN Biotechnology Fellowship: 2001-2003
Honorable Mention, National Science Foundation Graduate Research Fellowship: 200
2
First Place AIChE National Student Paper Competition, Chondrocyte-alginate Hydro
gel Research: 2001
Publication
"Design and Application of an Oscillatory Compression Device for Cell Constructs
," Biotechnology and Bioengineering. Cassino, T.R., Anderson, R., Love, B.J., Hu
ckle, W.R., Seamans, D.K. and Forsten-Williams, K. Volume 98, Issue 1, September
1, 2007. Pages 211-220.