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Process Engineer

Location:
Morgantown, WV
Posted:
September 10, 2013

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Resume:

April Oreane Lovingood

*** ***** *** **** *****

Morgantown, WV 26501

724-***-****

ab686r@r.postjobfree.com

ab686r@r.postjobfree.com

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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