Inteldot Benefits Overview

Manages pharmaceutical QC laboratory capital projects from concept through commissioning, qualification support, turnover, and closeout. Develops execution plans, schedules, budgets, and resource plans; leads design, procurement, contractor, and change-control activities; coordinates Engineering, QC, Quality, EHS, Maintenance, construction, and commissioning teams; manages risks and compliance; and reports project status, KPIs, milestones, and issues to leadership.

Support regulated manufacturing operations, quality systems, process validation, procedures, training, and new product introductions. Own manufacturing documentation, change controls, non-conformances, CAPA investigations, process monitoring, root-cause analysis, and compliance activities. Assess process performance, troubleshoot issues, support validation protocols and reports, participate in regulatory inspections, and provide project management support for process or equipment modifications. Requires bilingual Spanish and English communication.

Provides advanced engineering support for pharmaceutical manufacturing, pilot plant, utilities, and capital projects. Evaluates equipment failures, performance, reliability, maintenance, and qualified state; prepares technical assessments and justifications; supports deviations, CAPAs, change controls, risk assessments, and FDA commitments. Collaborates with manufacturing, quality, validation, automation, maintenance, vendors, and project teams. Develops engineering solutions, supervises technical staff, coordinates design consultants, and manages project budgets and deliverables under cGMP requirements.