Teams at Inteldot

Support plant Quality Assurance across manufacturing, process validation, regulatory compliance, and quality systems. Responsibilities include reviewing batch records and manufacturing documentation, leading deviations, CAPAs, investigations, audits, change controls, risk assessments, and validation activities. The role supports new product introduction, commissioning and qualification, environmental and facilities programs, lot disposition, and regulatory inspections while collaborating with manufacturing, QC, engineering, and other cross-functional teams. Bilingual English and Spanish communication is required.

Supports manufacturing and quality systems, including change control, non-conformances, CAPA, process validation, procedures, training, and new product introductions. Evaluates process performance, investigates deviations, performs root-cause and trend analysis, supports validation protocols and reports, and helps implement process or equipment modifications. Maintains documentation, monitoring parameters, corrective actions, and regulatory inspection readiness while collaborating with manufacturing and cross-functional stakeholders.

Provides advanced engineering support for process optimization, operational troubleshooting, system modifications, experiments, and capital projects in manufacturing and pilot plant environments. Develops complex technical solutions, engineering procedures, budgets, and design documents. Coordinates engineers, technicians, consultants, and cross-functional teams across manufacturing, validation, quality, facilities, and process development. Requires commissioning and qualification experience with parenteral products, vision systems, device assembly, and packaging lines.