Paul Scalia

Promoted to Senior Engineer role overseeing Network MES operations across PDS BI&T manufacturing sites, with expanded scope covering multi-site process standardization and MES governance. Lead cross-functional initiatives to harmonize MES recipe design, GMP documentation standards, and change control processes across manufacturing network.

Co-founded and launched IEPvocate, an AI-powered SaaS platform that helps parents analyze Individualized Education Programs (IEPs) and prepare for school advocacy meetings; own the full product lifecycle from architecture through production deployment. Engineered a two-pass IEP document analysis pipeline on the Anthropic Claude API, plus three generative tools: meeting question generator, advocacy

Authored and maintained Electronic Batch Records (EBRs) and GMP recipes for cell therapy programs in Syncade MES; co-led recipe implementations at 3 sites, including Bothell Next Gen, and independently delivered Bothell's recipe process parameterization. Partnered with Manufacturing, Quality, and Validation teams to identify documentation gaps, resolve discrepancies, and drive document lifecycle t

Provided GMP-compliant operational support for MES, DCS, SCADA, and other computerized systems in a large-scale biologic manufacturing facility under 21 CFR Part 11. Served as site point-of-contact for planned/unplanned system outages; coordinated with affected teams to minimize manufacturing impact and authored corrective action documentation.

Analyzed and documented a proprietary data entry application for R&D departments; developed user manuals and authored process improvement recommendations presented to IT leadership and company executives. Collaborated with an international team to gather requirements, identify reporting gaps, and develop long-term process improvement proposals — delivering final project one month ahead of schedule

Bachelor of Science in Biomedical Engineering from Rensselaer Polytechnic Institute, completed in December 2020.