Jobs at Inteldot

Supports pharmaceutical manufacturing and quality systems, including procedures, change controls, non-conformances, CAPA, process validation, training, process monitoring, troubleshooting, regulatory inspections, new product introductions, and equipment or process modifications. Authors investigation reports, manages corrective actions, evaluates process performance, analyzes validation data, and provides project management support for manufacturing improvements.

Leads commissioning, qualification, validation, characterization, and process optimization activities in pharmaceutical manufacturing and capital-project environments. Develops C&Q strategies, risk assessments, plans, schedules, protocols, and reports; oversees FAT, SAT, IQ, OQ, and PQ execution; ensures GMP, FDA, EMA, data-integrity, and documentation compliance. Manages change controls, deviations, CAPAs, vendors, and cross-functional collaboration while providing technical mentorship and stakeholder updates.

Supports the Quality Assurance program across manufacturing, process validation, regulatory compliance, and quality activities. Reviews and approves validation protocols, investigations, CAPA records, change controls, risk assessments, work orders, environmental reports, and manufacturing documentation. Leads investigations, site audits, cross-functional quality initiatives, and regulatory interactions. Supports NPI, automation, facilities, and environmental programs, while authorizing lot disposition and shipment release.

Support manufacturing and quality systems in a regulated life-sciences environment: manage SOPs, change control, non-conformances/CAPA, process monitoring, troubleshooting, training materials, process validation support, and NPI/project activities. Serve as document owner and assist with investigations and process improvements.

Support pharmaceutical/biotech manufacturing by troubleshooting equipment/processes, designing and implementing system modifications, driving continuous improvement, managing technical documentation and compliance activities, and coordinating cross-functional teams during 24/7 non-standard shift operations.

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.

Lead end-to-end advanced analytics projects for Puerto Rico drug product operations. Collaborate cross-functionally to build predictive models, visualizations, and automation using Python, SQL, and BI tools; support GMP validation, documentation, and compliance; communicate findings to stakeholders and support non-standard shifts as needed.

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.

Support site Quality Assurance under minimal supervision: review and approve validation protocols/reports, technical documents, change controls, CAPAs, investigations, audits, and release sanitary utilities. Represent QA on NPI and CCRB, support automation, facilities, environmental programs, and own site quality procedures.

Lead complex engineering projects for process optimization, equipment design, and troubleshooting in pharmaceutical/medical device manufacturing. Develop policies, supervise small engineering teams, work cross-functionally on design, validation, and capital projects, and coordinate external consultants and budgets to implement large system or facility modifications.

Supports pharmaceutical quality assurance across manufacturing, process validation, regulatory compliance, and quality systems. Responsibilities include batch record and production review, deviation and CAPA management, change control, validation oversight, audit and inspection support, quality risk assessment, new product introduction, and continuous improvement. The role collaborates with manufacturing, validation, quality control, engineering, warehouse, and other functions while advising management on quality, compliance, supply, and safety risks.

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.

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.

Lead design and execution of experiments for sterile drug product process development and validation. Support aseptic filling, process characterization, PPQ, technology transfer, and commercial readiness. Analyze data (JMP/Minitab), author validation protocols and technical reports, work cross-functionally to ensure GMP compliance and contamination control, and drive continuous process improvements.

Coordinate marketing programs, congresses, educational events, and communications across cross-functional stakeholders. Manage vendor coordination, budgets, timelines, approvals, and audit-ready documentation. Serve as operational liaison among Marketing, Sales, Medical/Clinical, Compliance, Legal, and Finance. Improve workflows, develop SOPs/templates, and ensure compliance for regulated commercial activities.

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.

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.

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.