Serena L.

Flood
6031 Clapton Drive
Wake Forest, NC 27587
Cellular: (919) 671-9890
Home: (919) 841-4149
Email: fsaaa3d6@westpost.net
Key Skills and Knowledge Base
Microsoft Excel/Word/Project/Visio Six Sigma Certification Project Management (P
MP) training
Non-product software validation Process Cost Analysis Lean Manufacturing/ Kaizen
Process Validation Design of Experiment (Minitab) Kepner Tregoe
FMEA/Risk Assessment Performance Development Plans Technical Process Trainer (St
art-up)
CAPA/Failure Investigations FDA Process Validation Guidelines Project and Busine
ss Strategy development
Work Experience
2005-Present Biomerieux, Inc. Durham, NCSr. Process Engineer (In-Vitro Diagn
ostics)* Executed and developed process model/DOE for slurry filling equipment u
sing Minitab software. * Developed process validation strategy for validation of
an expanded production filling line.* Developed mixing study strategy for media
bulking process to determine the homogeneity of the mixing process. * Character
ized the mixing process for media bulking process by determining the optimal equ
ipment parameters.* Responsible for developing engineering study protocols and r
eports to establish baseline capabilities for the media bulking process for batc
h sizes ranging from 1700 to 3000 Liters.* Team Lead and SME responsible for dri
ving the procurement process for equipment for new product line, responsible for
RFP and RFQ development, technical review and generation of Vendor Selection Ma
trix. * Key member of Kaizen team, organized to streamline the site validation c
ycle, including the origination of the protocol to closure of the validation. In
cluded revision of site and corporate validation procedure to include process ch
anges to reduce cycle time. * Successfully completed coursework and assessment f
or Six Sigma Green Belt certification. * Developed and executed validation strat
egy for non-product software validation of quality control product release Excel
spreadsheets. * Executed process validations on Anti-coagulant product line, co
nducted required training. * Led Failure Mode and Effects Analysis (FMEA) for ne
w production equipment for new product line.
1998-2005 Convatec-Bristol Myers Squibb Company
Greensboro, NCValidation/Process Engineer/Manufacturing Team Leader (Medic
al Devices)* Site SME responsible for conducting process validations on existing
and proposed manufacturing lines.* Six Sigma tools (graduate studies) to develo
p optimum operating conditions for an extrusion and lamination process designed
to manufacture pediatric urine collection products resulting in an improvement i
n process performance metrics such as DPMO, OEE and Cpk.* Site technical represe
ntative for injection molding process validation for mold cavity improvements.*
Conducted CAPA investigation on cosmetic and functional medical device defects.
Conducted root cause analysis to defect determination.* Application of FDA Proc
ess Validation guidelines for medical devices existing and proposed manufacturin
g equipment.* Responsible for developing guidelines and approval procedures of t
he Change Approval Board (CAB), designed to risk manage changes that impact the
manufacturing environment.* Conducted validation on medical device manufacturing
equipment via engineering studies by establishing the baseline process capabili
ty index (Cpk) * Developed surface response models to characterize the ultrasoni
c and heat welding processes.* Team lead responsible for conducting process vali
dation of adhesive extruder. Developed engineering approach, project timeline,
resource allocation and budget. Engineering studies used as reference and templ
ate for future adhesive mass extrusion process validations.1995-1998 Loparex (Re
xam Release) Eden, NCProcess Engineer/Manufacturing Team Leader (C
onverting)* Managed 15+ manufacturing process technicians in a self-directed wor
kforce comprised of maintenance, QA, instrumentation and programming.* Functiona
l manager responsible for plant layout and logistics for release liner start-up
facility.* Functional manager for silicone coating and slitter/rewind functional
areas.* Functional Manager for the slitter process and packaging operations, re
sponsible for developing training program.* Developed technical promotion struct
ure to facilitate career advancement for process technicians.* Implemented fully
automated packaging and handling system constructed of shrink and stretch wrapp
ing equipment for continuous operation.
Education/Training
Project Management (PMP) Certification Exam Prep Training Course, 2010Wake Techn
ical Community College Raleigh, NCProcess Validation-Impact the FDA Guidance, 20
10The Tungstein Shield GroupSix Sigma Green Belt Training, 2006Value-Train Train
ing GroupDurham, NCMasters in Business Administration, Operations Management, 20
03Wake Forest University -Babcock Graduate School of Management Winston-Salem, N
CB.S. Chemical Engineering, 1994Tuskegee UniversityTuskegee, AL