For Eli Lilly and Company (Indianapolis, IN): MES Recipe Authoring - Creating Syncade MES recipes and master data for several manufacturing projects. Authoring requirements and validation documents. - Using Jira for project management. - Automated peer review checks with Python. This reduced the peer review time from several hours to minutes. This also mistake-proofed the review by catching every issue.For Lonza (Portsmouth, NH): MES Evaluation - Analyzed options for a new facility's MES implementation. This involved weighing the strengths and costs of several MES vendors.For Moderna (Boston, MA area): Continuous Improvement - Facilitating OQ and PQ guideline improvements using DMAIC (i.e., Lean Six Sigma).For Moderna (Boston, MA area): Syncade MES Recipe Updates and Validation - Updated and validated recipes for Moderna’s clinical and commercial operations. - Used eValidation (Kneat) system to draft and execute validation documents.

For Genentech (South San Francisco, CA): MES Support - Supported manufacturing's Syncade MES testing activities. - Investigated MES issues to determine root cause and propose solutions. Drove solutions to closure. - Tested ERP / MES interface to verify it met user requirements.For Lonza (Portsmouth, NH): MES Updates – Updated Syncade MES system from Manufacturing or Process Development department requests. - Authored two recipes using pre-validated work instructions. Since the work instructions are already validated, the amount of validation work for the recipes was greatly reduced. - Wrote Excel macro to create recipe comparison reports for reviewers. Using the macro reduced the amount of time it took to create the reports from over one hour to seconds per report.For Genentech (Hillsboro, OR): Software Validation – updated and executed 35+ test script documents and requirements traceability matrices for Emerson Syncade MES qualification. Testing included authoring and publishing recipes, creating equipment classes and equipment, creating material master records, and executing behaviors.For Jabil (formerly Johnson and Johnson, Monument, CO): Time Studies - Collected, analyzed, and managed time data that were used for estimating the time and cost of producing goods. Managed the work of six contractors to collect and analyze data over a two-month period. We managed time data for more than 100k materials across 396 work centers. Finally, wrote user requirements and managed a team of offshore contractors to develop and deploy an application to organize and manage Jabil's time study data.

Helped develop our Siemens Simatic IT manufacturing execution system (MES). I was involved with developing and validating 28 recipes for one manufacturing process. I created process instructions using XFP, interfaced with our process control systems (DeltaV), enterprise resource planner (JDE), laboratory information management system (LIMS), and data historian (OSI-PI). Also, I worked with our quality and manufacturing departments to ensure we built the system to their liking. Finally, we documented our work per regulatory requirements.

This was a 9-month rotational program, and my first rotation was at Baxter's St. Paul manufacturing plant. There I supported our manufacturing process by working with our engineers, manufacturing technicians, and regulatory analysts. I helped our team improve our cleanroom's safety by reducing our technicians’ exposure to carcinogenic fumes. Also, I utilized Baxter’s CAPA documentation systems and lean / six-sigma problem-solving process to facilitate our projects. Finally, I participated in a design of experiment project and used statistics to analyze our data.For my second rotation, I was a supervisor in Baxter’s analytical quality control lab at Thousand Oaks. In the lab, I led a team of eight Quality Analysts and helped them develop their technical and leadership skills. I learned how lab operations work and how the lab and manufacturing work together.For my third rotation, I supervised a team of 20 Manufacturing Setup Technicians in Los Angeles’ fractionation process. I learned about our automated fractionation process, and the people operating it. In addition to receiving exposure to the fractionation process, I received training and experience in operating their DeltaV automation software.

Worked with a team developing our downstream purification processes. I designed and ran protocols on General Electric’s ÄKTA Pilot. Lastly, I helped our team write SOPs describing our manufacturing process.

Helped our team develop a fed-batch fermentation process that conformed to good manufacturing practices. Also led initiatives to automate our fermentation process by designing programs in New Brunswick’s Biocommand software.