Nick Monteleone Email & Phone Number

San Francisco, CA, US

Blue Bell, Pennsylvania, US

Blue Bell, Pennsylvania, US

• Developed Python scripts for electronic form editing, documentation, and testing to automate manual tasks and successfully deploy a client site workflow application, utilizing docker containers for hosting.
• Presented to the company on the tool creation process and added the tool as a platform Python package.Provided TypeScript consulting for a client to implement their site’s first HTML5 control system displays.
• Led project to upgrade & virtualize a multi-server control system for a biotechnology firm, including validation testing delivered to client quality group for an system release within the scheduled time frame.

Blue Bell, Pennsylvania, US

• Full Stack Web Development Program at Rithm SchoolSoftware Engineer Internship Experience:
• Utilized Django & Python to develop backend, frontend, and admin applications for 80,000+ line codebase.
• Implemented tagging model to interface with five other app models. Evaluated three possible approaches for relating tags with other models before moving forward with the best option.
• Performed novel integration for system to interface with external API for sending reminders to users.
• Created and submitted four issue-closing pull requests with 100% test coverage.
• Assessed tasks using agile methodology to assign story points and evaluate project velocity.

San Rafael, CA, US

• Designed and implemented GxP DeltaV virtual and physical network infrastructure for BioMarin's Novato manufacturing sites. Developed documentation, change control, and testing for qualification.
• Planned and designed network architecture for Production and Qualification DeltaV systems. Supervised work by contractors for installation and testing.
• Installed and tested development distributed control system for engineer and operator training, including a simulation environment.
• Developed documentation, drawings, and testing for qualification of Allen-Bradley PLC and FactoryTalk HMI system upgrade project.
• Led project for reconfiguring DeltaV M-Series controllers to adapt BioNet reactor system to meet updated requirements for lab users.
• Executed code configuration and testing for monitoring additional controlled temperature environments on Yokogawa DX and GX Chart Recorders.

San Rafael, CA, US

• Led team of three for engineering projects and day-to-day support for the PI System - delivered insights for manufacturing operations and facilities through data source configuration with analytics, reporting, and.

San Rafael, CA, US

• Developed standardized GMP reports for Review-by-Exception batch records by collaborating with manufacturing and quality to align alarm strategy in S88 automation recipes with risk assessments and product license.
• Created and executed acceptance testing for data contextualization and batch report templates.
• Performed database creations, infrastructure upgrades, and report implementation under GMP change control, including change owner role for several first-in-kind implementations.
• Managed two contractors to complete advanced reporting project. Guided team's intern through a project to customize collection of sample data for lab bioreactors.
• Provided on-call technical support for PI data collection, reporting, and displays.
• Responsible for providing system training and developing work instructions/best practices documents, along with managing user access.

San Rafael, CA, US

• Deployed new web-based data visualization tool by tailoring software for user needs, demoing key features, and creating training material.
• Conducted PI tag and OPCDA/OPCAE interface additions, modifications, and deactivations under change control for new and existing equipment.
• Investigated deviations from normal data system behavior and executed appropriate corrective/preventative actions.
• Organized week-long global summit for PI System collaboration at BioMarin's Shanbally, IRE facility.
• Generated and updated GMP specifications (URS, FRS, SDD, & CS documents) for PI System components.

Boulder, Colorado, US

• Worked on projects to engineer regrowth of bone tissue using fibrous electrospun hydrogels as scaffold for pre-osteoblast cells
• Created and executed experimental design for chemical/mechanical optimization of biomaterials for Biological Sciences Initiative funded project
• Analyzed data for electrospinning fibrous hydrogels using thiol-ene crosslinking
• Completed senior thesis study on cell differentiation from an optimized scaffold

San Rafael, CA, US

• Developed, implemented, and presented new process monitoring tool for GMP biologic drug manufacturing facility.
• Utilized PI Asset Framework to organize process PI tag data points and notify users for alarms.
• Designed PI ProcessBook trends displays and P&ID views for upstream and downstream equipment.
• Integrated VBA code into displays to enhance user navigation ability and add Batch ID search.
• Led meetings with operators and systems engineering to facilitate user feedback.

Bachelor Of Science In Engineering (B.S.E.), Chemical And Biological Engineering

Full Stack Web Development, Computer Science