Teams at Pinnaql, Inc.

Owns and supports aseptic filling equipment and related systems in a pharmaceutical or biotech manufacturing facility. Responsibilities include troubleshooting, investigations, deviations, CAPAs, change controls, maintenance and vendor coordination, equipment qualification, commissioning, startup, documentation review, and GMP compliance. The role serves as the primary technical contact for vial, syringe, and isolator-based filling systems while collaborating with Engineering, Manufacturing, Maintenance, Automation, Quality, and Validation teams.

Leads manufacturing engineering operations, technical projects, process improvement, and validation activities. Provides mentorship to associate engineers and COOP students, develops and executes IQ/OQ/PQ protocols, applies statistical analysis, resolves complex manufacturing challenges, and ensures GMP, quality, and compliance standards are met while improving operational efficiency.

Leads the Quality organization for a 503B outsourcing facility, overseeing the QMS, QA, QC, regulatory compliance, inspections, audits, deviations, CAPA, validation, documentation, laboratory activities, product disposition, and continuous improvement. Partners cross-functionally to ensure cGMP, USP, FDA, and pharmacy-regulatory compliance while protecting product quality and patient safety. Manages quality personnel and supports operational growth, inspection readiness, complaints, recalls, and regulatory reporting.