Aaron K.

Experience

• 

  Wake Technical Community College

  Jan 2018 - May 2018

  Mycology Lab Assistant

  My job was to assist Dr. Stewart in the development of an efficient small-scale mushroom culturing process. I dealt with lab equipment and agar plating needed to turnover spores to mycelium growth and mushroom capping. The majority of my duties were aimed to develop procedures that reduced mold and bacteria contamination, organized mycelium archive to pave a foundation for future research, and refining a well-established process for culturing mushrooms for research.Because of my work in the lab Dr. Stewart is happy to say that the lab has progressed to researching the antibiotic and genetic properties of several mushrooms strains. Show less

• 

  North Carolina State University

  Sept 2018 - May 2019

  Undergraduate Researcher

  Prepared Drosophila Melanogaster embryos used in studying how cells in multicellular organisms communicate and make decisions.Prepared flies for crossing by sorting through males and females based on sexual maturity of both wild type and iRNA producing type. Kept sanitary conditions in order to accurately perform scientific trialsFollowed strict and precise instructions as to maintain experimental integrity Worked autonomously, trusted to keep the trials on track, untampered with, and on time Show less

• 

  FUJIFILM Diosynth Biotechnologies

  Apr 2019 - Apr 2020

  Facilities Engineer Intern

  • Executed validation protocol for bioreactor clean in place operations, air handling units, and freezers using riboflavin, SAS units and Metone Particle Counter, and a Kaye Validator, respectively• Lead a Change Control including shutdown of a water for injection still, installation of a pressure reducing valve, completion of Installation Operation Qualification and Performance Qualification, and QA release of equipment• Edited P&IDs, authored SOPs and HDSs, and maintained the engineering library • Engineered pharmaceutical grade water purification systems• Coordinated the design and installation of a glycol filtration skid• Projected material of construction options for a bioreactor in response to chloride pitting concerns • Located and diagnosed pipe corrosion using FLIR and coordinated with contractors to replace pipes of concern• Specified and purchased centrifugal pumps and accompanying variable frequency drives• Advised the chiller purchase and installation by calculating current heat duty and projected duty needed• Created and implemented a protocol for sanitizing redundant WFI pumps as to keep a continuously pressurized system per GMP requirements Show less

• 

  IPS-Integrated Project Services, LLC

  Jun 2020 - Jul 2022

  Process Engineer I

  Designed a single-use mAb purification process using UF/DF, VF, as well as AEX, CEX and ProtA chromatography.Redesigned buffer preparation strategy by developing concentrated buffers and integrating inline dilution with an AKTA Ready chromatography skid. This novel strategy reduced buffer bin footprint and optimized process workflows.Used SchedulePro to model operations for gene therapy facilities considering equipment occupancy, staffing, material handling, product storage, and available utilities. The model successfully increased output by one batch per campaign.Sized chromatography columns using mass balances, product characterization, dynamic binding capacity and buffer steps.Performed a study on a neutralization skid's max processing load in response to a pH alarm, ensuring it met design parameters. The skid was spec'ed to neutralize 330gpm of CIP waste (pH range 2-12) with 2gpm H2SO4 and NaOH.Authored BFDs and PFDs on MS Visio, as well as P&IDs on AutoCAD and Plant3D.Modeled fluid dynamics on a WFI powder induction process using Pipeflo. Sized pipes, pumps, valves, and vessels.Collaborated with architects on process layouts, solving problems with clean rooms grades, personnel flow, and footprint.Wrote specifications for chromatography skids, heat-exchangers, worked to procure equipment from vendors.Retrofitted a pre-existing manufacturing suite for a new small molecule drug formulation process. Existing room architecture and utilities were repurposed to serve new equipment and engineer an efficient, safe, and cGMP design.Mitigated single-use equipment shortages and lead times, redesigning processes and working with vendors to fit procurement deadlines and meet the client's production date deadline.Manages client expectations during an aggressive timeline. Collaborated intensely on potential designs, as well as, using prior experience to advise the client on possible drawbacks to their designs.Maintain and utilize OSHA 10-hour certification Show less

• 

  FUJIFILM Diosynth Biotechnologies

  Jul 2022 - now

  Commercial Process Engineer II

  • Dispositioned 14 batches in a two week period by performing technical impact assessments, investigations, andgenerating CAPAs for outstanding deviations, including a low purity trend, a bioburden trend, and a machine reliabilitytrend• Travelled between sites to support the Fujifilm network, participating in quality improvement projects and deviation resolution needed for facility startup.• Executed major process changes/improvements including the validation and qualification of an improved elution strategy for an AEX chromatography column• Authored annual Continuous Process Verification (CPV) report providing statistical analysis on process analytics and process recommendations for continuous improvement.• Identified process inefficiencies through real-time process data monitoring and administered solutions for continuous improvements, including a low purity trend and identifying early indicators for low purity batches and potential root cause• Authored and executed an Engineering Test Plans (ETP) by coordinating with manufacturing to hit new targets and coordinate sample submissions with QC. Then authored a summary report concluding ETP data analyses and discussions• Administered training to manufacturing after making process/equipment changes• Supported Problem Analysis (PA) by performing 5 why, 6M investigations, and GEMBA/Kaizens• Provided technical support in troubleshooting equipment during manufacturing runs, including production bioreactors, depth filter stacks, chromatography skids/columns, UFDF skids/membranes, single-use mixers, and pressure vessels.• Acted as technical project lead for the client, participating in weekly client meetings and supporting technical discussions• Worked with manufacturing and Unicorn 7 method writers to solve a multiple chromatography issuecaused by pressure alarms and level alarms Show less