Teams at QRC Group, LLC

Provides engineering support for daily manufacturing operations through troubleshooting, process optimization, equipment and system modifications, upgrades, and replacements. Collaborates with manufacturing, maintenance, quality, validation, utilities, and facilities teams. Supports deviations, equipment qualification, process validation, procedures, training, new product introductions, experiments, and capital projects. Monitors operational performance, recommends solutions, and provides technical mentorship. Requires support for 24/7 non-standard shifts, including extended hours and weekends.

Supports packaging equipment and production processes in a GMP-regulated environment. Responsibilities include process characterization, validation, monitoring, optimization, CAPA management, technical report writing, statistical analysis, DOE, root cause investigations, and resolving production issues. Requires flexibility to work first- or second-shift schedules, including nights, weekends, holidays, and extended hours.

Supports commercial pharmaceutical and biotechnology manufacturing operations, with emphasis on sterile injectables, drug-device combination products, packaging, labeling, troubleshooting, investigations, process validation, and GMP quality systems. Leads projects, authors technical documentation, analyzes process performance, supports improvements and technology transfers, and provides on-floor technical guidance. Collaborates with Manufacturing, Quality, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory teams. Requires an engineering degree, relevant experience, and full English-Spanish bilingual proficiency.