Jobs at Inteldot

Provides engineering support for pharmaceutical manufacturing operations, including process optimization, troubleshooting, system modifications, equipment qualification, validation, deviations, and capital projects. Acts as a technical resource across manufacturing, maintenance, utilities, facilities, quality, and validation teams. Monitors operational performance, mentors troubleshooting efforts, coordinates vendors, manages purchase orders, and supports 24/7 operations with occasional after-hours and weekend coverage.

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.

Provides advanced engineering support for pharmaceutical manufacturing, packaging, process optimization, troubleshooting, validation, and capital projects. Investigates deviations, defects, rejects, equipment alarms, and yield losses using root-cause analysis and statistical tools. Authors technical and quality documentation, supports GMP systems, collaborates across manufacturing and quality functions, and coordinates engineers, technicians, consultants, and multidisciplinary project work.

Provides engineering support for pharmaceutical manufacturing, including process optimization, troubleshooting, equipment and system modifications, validation, qualification, deviations, CAPAs, and new product introductions. Analyzes operational results, monitors manufacturing performance, conducts root cause investigations, and collaborates with manufacturing, maintenance, quality, facilities, and validation teams. Supports non-standard shifts, including extended hours and weekends, as business needs require.

Provides site-level Quality Assurance technical support in a regulated life sciences manufacturing environment. Reviews and approves product master documents, oversees quality systems, investigations, incident management, validation, compliance assessments, and inspection readiness. Leads cross-functional stakeholders, evaluates manufacturing and process documentation, performs data trending and risk assessments, and supports quality decision-making. Requires strong project management, regulatory knowledge, technical documentation skills, and experience with commissioning, equipment validation, change controls, SOPs, and Kneat.

Provides technical Quality Assurance support for a regulated manufacturing site. Reviews and approves product master records and validation documentation, leads investigations and quality-system activities, assesses compliance and data trends, supports inspection readiness, and ensures manufacturing processes meet regulatory expectations. Coordinates cross-functional stakeholders across Manufacturing, Engineering, Validation, Regulatory, and Supply Chain while managing projects, documentation, change controls, and quality decisions.

Provides technical quality assurance support for a regulated life sciences manufacturing site. Reviews and approves product master documents, leads quality investigations, assesses compliance and risk, supports validation and commissioning activities, analyzes quality data, and ensures inspection readiness. The role collaborates across Manufacturing, Engineering, Validation, Regulatory, and Supply Chain while managing projects, documentation, change controls, and quality systems in accordance with applicable regulatory expectations.

Leads complex engineering, process optimization, troubleshooting, system modifications, validation, and capital projects in pharmaceutical manufacturing environments. Develops technical solutions, engineering procedures, budgets, and project recommendations while coordinating engineers, technicians, consultants, and cross-functional teams. Applies advanced engineering methods, data analysis, dashboards, automation, and digital tools to improve operations and manufacturing readiness.

Independently designs and leads scientific experiments supporting sterile pharmaceutical manufacturing, process development, characterization, validation, technology transfer, and commercial process support. Analyzes manufacturing data, interprets trends, develops protocols, authors technical documentation, supports investigations and change controls, and collaborates cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services. Provides technical leadership, resolves process issues, and advances continuous improvement and commercial readiness.

Supports pharmaceutical manufacturing facility quality systems, including deviations, CAPAs, change controls, documentation updates, and OEFM electronic forms. Investigates deviations, maintains inspection-ready records, evaluates facility and utility changes, and collaborates with Quality and engineering stakeholders. Also supports pest control program modernization, vendor coordination, validation documentation, regulatory compliance, and technical troubleshooting for HVAC, chilled water, and cooling tower systems.

Supports manufacturing and quality systems, including procedures, document control, process monitoring, non-conformances, CAPA, troubleshooting, training, process validation, regulatory inspections, new product introductions, and process or equipment modifications. Evaluates manufacturing performance, authors investigations, manages corrective actions, analyzes trends and validation data, and provides project management support for process improvements.

Support execution of manufacturing and quality systems for bioprocess operations: author and own procedures, troubleshoot process performance, manage NC/CAPA investigations, support process validation, training, NPI, and process/equipment change implementation while ensuring GDP and regulatory compliance.

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.