Jobs at Inteldot

Senior engineer responsible for process optimization, troubleshooting, and major system modifications in pharmaceutical manufacturing. Leads investigations (RCA/CAPA), change control, risk and microbial assessments, validation protocol development, MBR/BOM support, cross-functional campaign readiness, training, and on-floor troubleshooting for inspection and automation systems.

Lead equipment reliability, maintenance and process optimization for manufacturing. Own CMMS activities, drive downtime reduction, implement improvements, support troubleshooting, deviations, CAPAs, and ensure GMP/GLP compliance.

Support the site QA program for manufacturing: perform and approve equipment and process validations, review technical documents, manage quality systems (deviations, change control, CAPA), conduct investigations and audits, represent QA on NPI/CCRB, and support automation, facilities, and environmental programs.

Lead equipment ownership and reliability for manufacturing: manage CMMS work orders, PM strategy, spare parts, troubleshoot, implement improvements, define metrics, drive CAPAs and ensure regulatory and EHS compliance.

Support execution of manufacturing and quality systems in a regulated biotech environment: author procedures, troubleshoot processes, drive CAPA and process improvements, assist with process validation, training, NPI, and regulatory inspections while collaborating with operations, quality, and maintenance teams.

Lead planning and execution of pharmaceutical capital projects for the Barceloneta AIP portfolio from concept through closeout. Ensure projects meet safety, schedule, budget, cGMP and regulatory requirements; manage engineering, contractors, commissioning/qualification, validation, procurement, financial controls, risk mitigation, stakeholder communications, and documentation turnover.

Support and own manufacturing quality/process systems with minimal supervision: manage change controls, lead deviation and root-cause investigations, support validation, training, campaign readiness, MBR creation/revisions, CAPA/BOM assessments, and process improvement activities. Serve as a peer-recognized specialist and provide floor troubleshooting and regulatory inspection support.

Support execution of manufacturing and quality systems (deviations, CAPA, process validation, procedures, training, NPIs). Troubleshoot floor operations, collect and analyze process data, author investigation reports, support process validation, and participate in regulatory inspections and equipment/process changes.

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.

Lead design, commissioning, qualification, validation, startup, and operation of CO2 cold rooms and ASRS. Serve as automation SME, drive system integration, ensure GxP/cGMP compliance, support CSV/CQV, train operations, and collaborate with facilities, QA, IT/OT, vendors, and packaging teams.

Support design, integration, commissioning, qualification, validation, and operation of automated packaging, ASRS, and AGV systems. Ensure GxP, 21 CFR Part 11, and FDA compliance, lead CQV and CSV efforts, collaborate with Quality, IT/OT, and vendors, and support PLC/HMI/SCADA controls, robotics, and industrial network integration.

Lead design, configuration, deployment, and support of Werum PAS-X MES for regulated pharmaceutical manufacturing. Translate requirements into MES solutions, configure MBRs and workflows, integrate with ERP/LIMS/automation systems, support validation/commissioning, ensure GxP and 21 CFR Part 11 compliance, troubleshoot issues, drive enhancements, and mentor junior engineers.

Support regulated manufacturing operations by troubleshooting equipment/systems, implementing process modifications, and driving continuous improvement. Manage documentation, change control, risk assessments, commissioning/decommissioning, and cross-functional coordination. Support deviations, equipment qualification, process validation, and non-standard 24/7 shift coverage as needed.

Senior engineer responsible for equipment reliability, maintenance strategy, CMMS ownership, troubleshooting, process optimization, CAPA implementation, and ensuring GMP/GLP compliance in a pharmaceutical manufacturing environment.

Serve as the primary technology liaison for Order-to-Cash, leading SAP OTC support, customer master data governance, BPX and customer master teams, system enhancements, UAT, production support, performance reporting, compliance, and continuous improvement to improve customer experience and operational efficiency.