Shay Pfeifer

• Participated in client meetings to meet customer requirements and align on project progress, technical updates, manufacturing challenges, etc.
• Leading a coating pan comparison study across nine manufacturing assets to generate data supporting process transfers.
• Completed technical reviews of development and validation reports, verifying data accuracy.
• Gained hands-on experience with batch record lifecycle management, change control workflows, and cross-functional execution of manufacturing process improvements.

• Conducted root cause analysses for sensor failures, identifying corrective actions that improved process safety and reduced equipment downtime.
• Supported recipe qualification of a new product through protocol execution, product sampling, and equipment troubleshooting.
• Executed coating pan improvement projects, strengthening process control.
• Provided daily manufacturing troubleshooting support, collaborating with cross-functional teams to resolve equipment issues, minimizing production disruptions.

• Successfully led and completed multiple equipment qualifications to support manufacturing capacity, feasibility studies, and new product implementation.
• Initiated validation efforts for a GMP site-wide security camera system, establishing a framework to support GMP compliance and data integrity for future site implementation.
• Coordinated annual environmental testing across GMP manufacturing areas, completed investigations related to high alert levels, and successfully achieved year-end testing requirements.
• Demonstrated attention to detail and regulatory compliance through consistent application of cGMP and GDP standards.

Balanced high-paced, customer-facing part-time employment with a full-time engineering curriculum.

• Supported after-school program operations and supervised students while balancing a full-time engineering curriculum.