NICHOLUS VAUGHAN

**** ***** ******, ***. * Baltimore, Maryland 21231

757-***-**** acy521@r.postjobfree.com

EDUCATION: BS in Microbiology and Immunology, Chemistry minor

University of Miami, Coral Gables, FL c/o 2008

QUALIFICATIONS

Biotechnology professional with experience in the following:

Writing and implementing IQ/OQ/PQ

Performing Temperature Mapping using Kaye Validators and Data Loggers

Providing technical support for end users of laboratory equipment

Troubleshooting mechanical and automated equipment issues

Development of medical devices

Establishing communication with technical services and laboratory clients to address issues related to validation

Familiarity with cGMP, GLP and GDP standards

ISO 17025, ISO 9001 and ISO 13485 environments

In-depth knowledge of SQL and Defect Tracking Tools

Becton Dickinson + Hunt Valley, MD + August 2016 - Present

Test Engineer

Provides Testing support to Sustaining activities

Executes planned Test cases to discover functional and nonfunctional System and Software anomalies with Risk impacts

Provides a detailed description of discovered anomalies to obtain resolutions from Software, System, Electrical and Mechanical Engineering teams

Supports Service/Training organization for troubleshooting customer complaints. Supports Software, Systems and Engineering Teams with troubleshooting, characterization and validation activities for Prototypes, Breadboards and Sub-Systems

United Therapeutics + Silver Spring, MD + October 2015 – February 2016

Manufacturing Engineer (Contract)

• Ensure proper operation and maintenance of Fill/Finish and Biologics equipment such as barrier isolated filling lines, blow-fill-seal machines, autoclaves, component washers, inspection units and packaging machines in an aseptic environment

• Troubleshoot complex, mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs

• Assist in writing/completing equipment SOPs, change controls and deviations

Amethyst Technologies + Baltimore, MD + May 2014 – March 2015

Validation Engineer

• Responsible for creating and executing equipment qualifications (IQ/OPQ), coordinating with vendors to attain calibrations for standards, developing and implementing SOPs, managing reference standards, executing validation protocols and tracking Amethyst-owned equipment.

• Coordinate and perform qualification and validation activities for equipment, laboratory instruments and steam sterilization

• Editing and drafting of technical documents such as protocols and calibration reports

• Perform temperature mapping using the Kaye Validator 2000 system

• Write final reports summarizing qualification work

Kerma Medical Products + Suffolk, VA + April 2013-May 2014

Product Research Assistant

• Researched information about scientific and technological topics for the purpose of enabling development of

new products, processes, and services.

• Wrote specifications of new product lines and integrated them into current manufacturing facility

Noxilizer, Inc. + Baltimore, MD + August 2011 – December 2012

Microbiologist/Engineering Assistant

• Conducted material compatibility studies on elastomers for use in O-Ring of RTS 360.

• Performed lethality experiments using steel disc biological indicators inoculated with G. Stearothermophilus, and placed in pre-filled syringes.

• Measured the levels of pH and used FTIR to measure chemical changes of pre-filled syringes and bioresorbable polymers.

• Wrote and edited SOPs for laboratory equipment.

• Mixed bacterial growth media, such as Tryptic Soy Agar, and performed general lab maintenance work.

• Managed assembly and testing of the critical components for use in the sterilizer, and used Excel macros to

establish standard deviations and variance of flow rate, relative humidity, evacuation time, and sterilant

concentration.

• Used Fourier Transform Infrared Spectroscopy to measure different variables such as Nitrogen Dioxide

concentration and relative humidity of chamber.

• Safely Built NO2 Sensors, performed crimping/electrical wiring work for solenoid valves, and constructed several

sub-assemblies.

• Performed maintenance and repair of vacuum pumps and other purchased components, and provided

troubleshooting solutions for optimal operation and results of the sterilizer.

Johns Hopkins School of Medicine + Baltimore, MD + 2010-2011

Research Program Coordinator

• Performed data management for Heme Malignancy clinical research trials for comprehensive metabolic panel, complete blood count, and other miscellaneous research.

• Learned protocols/schema and kept track of deviations studies approved by management.

• Tracked the before and after effects of patient progress through entirety of the study.

• Approved patients for admission to research studies.

• Reported adverse events, deviations, and presented weekly findings to research team

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