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Summary

I have been in the biotechnology sector for 8 years, working at different locations and roles. My broad background with diligent work ethic allows me to fit into adaptable situations and apply a range of skills. Participated in multiple projects and developed many end-user solutions, which empathize investigative skills and dynamic communication with groups. In addition, skillset on computers and technological application is very intuitive.

Work History

Production Engineer II

Oct 2016Present
Biogen Inc. - Research Triangle Park, NC
  • Part of team focusing on equipment qualifications at FATs to support Next Gen Manufacturing facility. Required attention to detail, maintaining punch-list items, and communication of discrepancies. 
  • Implemented a tracking schedule to align different stakeholders with information on the project status.
  • Co-developed a commissioning guide overview using Confluence (Wiki) platform as a training tool.

Validation Engineer

Jul 2012Oct 2016
Biogen Inc. - Cambridge, MA
  • Key member in cross-site team project to implement electronic solution for life-cycle management of validation documentation. Converting all validation governing systems to utilize Kneat Solutions software.
  • Developed and scheduled protocols for quality control, engineering and manufacturing activities equipment/cleaning qualifications. Contributed to validation reports and project plans, accessing core change controls and completing action plans. Equipment areas include: water systems, facility certification, chromatography systems, centrifuges, autoclaves, soil and clean hold studies and incubators.
  • Designed Microsoft SharePoint team-sites for multiple groups and departments. Created tracking pages and automated forms with notification workflows.
  • Maintained department compliance metrics in deviations, change controls, and corrective actions. This included protocol tracking and document revisions.
  • Completed a seed funding project assessing the feasibility of Rapid Microbiological Methods (RMMs) to reduce environmental monitoring sampling requirements due to instrument technology.

Manufacturing Associate III

Aug 2008Jul 2012
Biogen Inc. - Cambridge, MA
  • Subject matter expert and lead operator for multiple automated chromatography and ultrafiltration processes: utilizing automation (DeltaV/Unicorn) and manual systems.
  • Worked closely with engineering and validation teams on new equipment implementation: procurement, construction, commissioning and validation for chromatography and ultrafiltration systems.
  • Provided training to multiple operators (new and current) with the different equipment, procedures, and use of software.
  • Trained and supervised operators in Denmark facility upstart. Led the completion of purification operational qualifications on product hold tanks, viral filtration and ultrafiltration systems. Helped transitioned facility from non-GMP to cGMP state.
  • Developed training material and aides for operators of processes and equipment usage.
  • Developed and implemented a user-friendly electronic solution using PI ProcessBook for retrieving temperature data which saved labor time and space compared with manual recording system.
  • Collaborated with Manufacturing Sciences, Engineering and Documentation groups to create, update, or streamline operating procedures and batch production records.
  • Interacted daily with cross-functional team members to synchronize/track completion of projects.
  • Reviewed and maintained documentation to ensure adherence to cGMP requirements (procedures, batch records, logbooks, audits).
  • Participated in flexible work force program to assist other departments with appropriate work. 

Skills

Industry Software

                                  

 QUMAS MyCims, SpartaSystems TrackWise, Labware LIMS, Infor EAM, Agile PLM, Kneat Software,  Emerson Process Management DeltaV, PI ProcessBook, GE Unicorn, Umetrics SBOL, Atlassian Confluence
Proficient                                                              Microsoft Applications: Access, Excel, Word, PowerPoint, SharePoint, InfoPath, and Visio. 
Intermediate

Web design: HTML, CSS;  Programming: JavaScript, Java, C++, VBA, PHP, Python, Perl, Bash;  Operating Systems: Windows 10, Linux (Debian, Ubuntu), Mac OSX

Education

M.S. in Bioinformatics

2013In Progress
Northeastern University -- Boston, MA

B.S. in Biomedical Engineering

20032008
Rensselaer Polytechnic Institute -- Troy, NY