Process Engineer
Resume:
April Oreane Lovingood
Morgantown, WV 26501
**************@*****.***
***********@*****.***
EDUCATION
> Ohio University, Athens OH
Bachelor of Science in Chemical Engineering
Graduation Date: June 15, 2003
> Waynesburg University, Waynesburg PA
Bachelor of Science in Chemistry
Graduation Date: May 12, 2002
( Minor in Mathematics
EMPLOYMENT EXPERIENCE
> Aquion Energy - 08/20/2012-Current
Process Engineer: Aquion Energy, Mt Pleasant, PA
o Working with battery development for a startup company to ensure
successful commercial launch of the battery product
o Writing Design of Experiments to onboard new processing
equipment as part of the scale up process for anode and cathode
processing, primarily in the powder formulations
o Working with vendors to ensure a smooth installation and
equipment startup phase
o Certified ScrumMaster - Leading a scrum team to define Equipment
and Process Verifications
o Defining process flow, quality checks and key processing
parameters for cathode development
o Scheduling and assisting in managing six technicians
o Standup of the Quality laboratory for all physical property
testing, including XRD testing and radiation certification
o Writing SOP's and illustrated work instructions for quality test
procedures and manufacturing processes for both pilot scale and
production scale
o ERP system support and development
o Interviewing candidates for a variety of positions
o Review CAD drawings for new processing areas
o Conduct preoperational safety reviews for new and altered
processes
o Managing and ordering supplies to ensure day to day operations
> Mylan Pharmaceuticals INC. - 09/29/2003-08/17/2012
Process Engineer: Mylan Pharmaceuticals, Morgantown, WV (08/2007-
08/2012)
o Conducts and writes manufacturing/processing investigations
(Level 1, 2, and 3) for a 19.7 billion dose facility
. Investigates, writes detailed reports,
determines/implements corrective actions and preventative
actions; completing over 120 reports each year
. Provides information, as part of the Annual Product Review
team, to create and review submitted reports for the FDA
o Leads projects to improve solid dose manufacturing processes
. Improves processes for lean manufacturing and operational
excellence
. Executes process and product trend evaluations for Trending
Review Board to facilitate corrective actions and
preventative actions
o Writes detailed reports and summary memos in support of process
changes
o Coordinates regulatory affairs, validation team, and
manufacturing to ensure successful validation execution of new
product launches, product optimizations and corrective action
projects
o Launch, scale up and optimization of 6-8 new products each year
in a cGMP compliant environment with adherence to SOP's and
safety guidance
o Reviewed 350+ investigations for associate engineering team,
during Senior Engineer leave of absence
o Daily tracking of open investigations and in process
investigations through graphing
o Origination and maintenance of departmental SHARP site, created
for increased department communication
> Mylan LLC. (Special project for Mylan Pharmaceuticals INC.) - 02/2012-
07/2012
Process Engineer: Mylan LLC, Caguas, PR (02/2012-08/2012)
o Conducted process improvement projects to increase robustness of
production and packaging facility
. Worked with High Potent and Non-High Potent Product
processing
. Wrote and facilitated training for new and current SOP's
. Tracking and completion of corrective/preventative actions
associated with 483 observations
. Audit support during FDA Audit and other market audits
. Directed investigations and corrective/preventative actions
to optimize processing
. Process Control and Capability Study for entire product
line
Quality Control Chemist: Mylan Pharmaceuticals, Morgantown, WV
(09/2003-08/2007)
o Responsible for raw material, in-process, and finished product
analytical testing utilizing HPLC for 200+ products
o Tested for drug release, assay, uniformity, impurities, and
product stability
o Performed data analysis and produced written reports summarizing
test results
o Wrote analytical investigation reports, including action item
summaries and data tables
o Performed general maintenance on Waters HPLC instruments and UV
detectors
SKILLS
> Troubleshooting and optimizing manufacturing unit operations: High and
low shear Granulation, Fluid bed (drying, top spray granulation,
rotor, and wurster), Roller Compaction, Tablet/Pellet Compressing,
Encapsulation, Mixing/Blending, Milling, Jet milling, Coating
(functional and nonfunctional for tablets and beads), Tray drying,
Calcining, Gas and water absorption/adsorption, Distillation (batch
and continuous) and Filtration
> Vector Granulation Seminar Certification, Current GMP training,
experimental design and execution - training to support lean
manufacturing
> The use of fluid flow dynamics, heat transfer, mass transfer, and
kinetics to optimize manufacturing processes
> Certified ScrumMaster
> Ability to use and interpret the output of the following analytical
instrumentation: XRD, HPLC, IR, GC, TGA, and UV-VIS spectrophotometer
> Knowledgeable in the use of Empower, Millennium 32, SAP, Plex, LIMS,
QC Basic, SHARP, Trackwise, Google docs, Google forms, Dropbox, Lotus
Notes, and Microsoft Office including Word, Excel, Visio, and
PowerPoint
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