Teams at ISPV Inc.

Owns manufacturing equipment in the CMMS, including work orders, preventive maintenance, spare parts, reliability assessments, and change control. Develops equipment performance metrics, reduces downtime, optimizes maintenance strategies, and leads equipment improvement projects. Serves as a subject matter expert, supports troubleshooting, manages equipment-related deviations and CAPAs, and promotes environmental, health, and safety compliance.

Supports commercial pharmaceutical, biotechnology, medical-device, and combination-product manufacturing through process development, packaging operations, validation, investigations, and GMP quality-system activities. The role manages projects, troubleshoots packaging defects and equipment issues, authors technical documentation, analyzes process data, supports improvements and technology transfers, and collaborates with manufacturing, quality, engineering, validation, and regulatory teams.

Performs pharmaceutical quality assurance and validation activities, including facilities and utilities commissioning, computer system validation, equipment validation, risk assessments, change controls, SOP management, data integrity, documentation review, and syringe/vial inspection processes. Uses KNEAT, CDOCS, SCADA, TrackWise, and MAXIMO systems while applying risk management and decision-making techniques.