Job description:
En JCA, buscamos un CSV Consultant para apoyar proyectos en la industria regulada. Si tienes experiencia en validación, documentación y manejo de sistemas de manufactura, esta oportunidad es para ti.
Responsabilidades
Gestionar tareas, cronogramas y entregables de proyecto.Recopilar requisitos y apoyar el diseño de soluciones técnicas.Desarrollar documentos de validación: protocolos, scripts, riesgos, desviaciones y reportes.Ejecutar y revisar actividades CSV alineadas a GxP, 21 CFR Part 11 y Annex 11.Colaborar con QA y equipos técnicos para asegurar cumplimiento y auditor-readiness.Requisitos
Inglés avanzado.Experiencia en Life Sciences / Medical Devices o industrias reguladas.Conocimiento de arquitectura de sistemas, infraestructura e integraciones.Capacidad para manejar múltiples prioridades y trabajar de forma independiente.¡Excelente oportunidad para comenzar tu carrera y desarrollar habilidades técnicas reales! ¡Aplica hoy y eleva tu futuro profesional con JCA!
Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The Construction Coordinator is responsible for overseeing day-to-day construction activities, ensuring projects are executed safely, on schedule, and in compliance with design specifications, regulatory requirements, and EHS standards. This role works closely with project managers, contractors, and cross-functional teams to support successful project execution from pre-construction through closeout.
Key Responsibilities:
Collaborate with the Project Manager to develop and execute Construction Execution Plans.Coordinate with construction firms to define field support requirements.Set up job sites and support pre-construction activities.Lead and participate in construction meetings and field coordination sessions.Manage project punch lists, issues tracking, and progress updates.Review installed materials and equipment to ensure compliance with drawings, specifications, and codes.Verify “as-built” conditions and support project closeout activities.Oversee daily construction activities and contractor performance.Ensure compliance with all permitting requirements (e.g., NPDES, CES plans, construction permits).Enforce adherence to design standards, safety regulations, and quality requirements.Maintain proper site housekeeping and organization.Coordinate EHS permits, inspections, and contractor safety requirements.Ensure all contractors and subcontractors are properly trained and compliant with safety standards.Support change control execution and documentation verification against specifications and drawings.Maintain contractor safety documentation and ensure compliance with project/site procedures.Facilitate daily risk assessments and safety discussions with contractors.Support schedule planning, including two- and three-week look-ahead plans.Participate in commissioning, verification, and start-up activities.Coordinate warranty-related work with contractors as needed.Ensure environmental and safety compliance, including proper handling and approval of materials used on-site (e.g., paints, oils, refrigerants).Document daily construction activities and ensure proper tracking of project-related work orders.Requirements:
Bachelor’s degree in Engineering, Construction Management, or related field (or equivalent experience).Experience in construction coordination or project execution within industrial or regulated environments.Strong knowledge of construction practices, safety regulations, and permitting requirements.Experience managing contractors and coordinating field activities.Familiarity with EHS programs and compliance standards.Strong organizational, communication, and problem-solving skills.Ability to work in a fast-paced, cross-functional environment.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
About the Role:
The Senior Automation Technician Support role provides advanced technical support for industrial automation systems within a cGMP-regulated environment. This position is responsible for supporting configuration, integration, troubleshooting, and validation of automation and data systems across Manufacturing and Utilities, ensuring compliance with regulatory standards and data integrity requirements.
Key Responsibilities:
Provide technical support for industrial automation systems including PLCs, HMI, SCADA, and DCS platforms.Configure and troubleshoot Rockwell Automation platforms (PLC5, SLC500, ControlLogix, CompactLogix), Siemens, and equivalent control systems.Support industrial communication protocols and gateways including OPC UA/DA, Modbus TCP, and Profibus.Configure and maintain interface servers (e.g., Kepware) and MES connectors.Support data historians and contextualization tools such as OSI PI Data Archive, PI Vision, and Event Frames for batch/lot tracking, analytics, and OEE monitoring.Perform system configuration including PLC/DCS tags, MES interfaces, OPC gateway setup, and historian/event framework templates.Support and execute automation validation lifecycle activities including requirements, design, and testing.Author and execute validation documentation such as IQ/OQ protocols, TMX, QRS, and other CSV deliverables.Utilize Kneat for validation documentation management and execution.Ensure compliance with cGMP regulations, data integrity standards, and internal SOPs.Collaborate with cross-functional teams (Manufacturing, Quality, IT, Engineering) to support operational and project activities.Requirements:
Associate’s or Bachelor’s degree in Engineering, Automation, or related technical field.Hands-on experience with industrial automation systems (PLC, SCADA, HMI, DCS).Experience with Rockwell Automation and/or Siemens platforms.Knowledge of industrial communication protocols (OPC, Modbus, Profibus).Experience with data historians (OSI PI) and data contextualization is required.Strong understanding of Computer System Validation (CSV) and cGMP requirements.Experience authoring and executing validation documentation (IQ/OQ, TMX, QRS).Experience with Kneat Software is required.Strong troubleshooting, analytical, and communication skills.Must be authorized to work in the United States without sponsorship.Location:
Puerto RicoAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
About the Role:
The Junior Automation Support Resource provides technical support for automated systems and process equipment within a cGMP-regulated manufacturing environment. This role assists in maintaining, troubleshooting, and supporting the implementation of automation and computerized systems in Manufacturing and Utilities areas, ensuring compliance with regulatory and quality standards.
Key Responsibilities:
Support the continuous operation of process equipment by assisting with basic programming and routine maintenance activities.Provide technical support under supervision for installation, configuration, integration, troubleshooting, and upgrades of automation systems.Assist in the maintenance and support of computerized systems including PLCs, HMI, DeltaV, FactoryTalk, SCADA, DCS/BAS, MES, and related technologies.Support software and hardware changes by assisting in system analysis and implementation of improvements in compliance with change control processes.Participate in automation and system implementation projects, supporting new technologies and integrated business applications.Collaborate with cross-functional teams (Manufacturing, Quality, IT, Engineering) to support operational and project activities.Assist in the installation, configuration, troubleshooting, and maintenance of systems in Manufacturing and Utilities areas.Ensure activities are performed in accordance with SOPs, cGMP regulations, and data integrity standards.Support documentation activities including system records, change controls, and validation documentation as required.Requirements:
Bachelor’s degree in Engineering (Electrical, Computer, Mechanical) or related field (or in progress).Basic knowledge of automation systems such as PLC, SCADA, HMI, or DCS.Understanding of cGMP environments, validation, and change control processes is preferred.Strong problem-solving skills and attention to detail.Good communication skills and ability to work in a team environment.Familiarity with manufacturing systems and networking concepts is a plus.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessCompany Overview
JC Automation is a global management and technology consulting firm dedicated to delivering innovative solutions across IT, automation, and regulatory compliance. We serve leading organizations, governmental agencies, and private institutions worldwide, providing expert support from system implementation to ongoing management and support.
Job Summary:
The Junior Validation Resource supports validation, maintenance, and change control activities within a cGMP-regulated environment. This role assists in the review, validation, and tracking of equipment, systems, and documentation changes, ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures.
Key Responsibilities:
Support the review and validation of changes to equipment, systems, and documentation in compliance with cGMP requirements.Assist in processing and tracking Service Requests related to maintenance and validation activities.Review maintenance records, change controls, and supporting documentation for completeness, accuracy, and compliance.Ensure all changes follow established SOPs, cGMP regulations, and data integrity standards.Support the update and revision of SOPs, maintenance procedures, and work instructions.Coordinate with Engineering, Maintenance, and Quality teams to support change control and validation activities.Maintain accurate and audit-ready records of approved changes, Service Requests, and documentation updates.Identify gaps, discrepancies, or missing information in documentation and support resolution efforts.Follow up on pending approvals, CAPAs, and assigned action items.Participate in internal audits, regulatory inspections, and compliance reviews as required.Utilize CMMS and/or document management systems to track and monitor activities.Provide administrative and reporting support aligned with validation and quality systems.Requirements:
Bachelor’s degree in Engineering, Life Sciences, or related field (or in progress).Basic knowledge of cGMP regulations, validation lifecycle, and change control processes.Strong attention to detail with a focus on compliance and data integrity.Good communication skills and ability to work in cross-functional teams.Familiarity with CMMS, document management systems, or quality systems is preferred.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The Sr. IT Projects Support role provides technical and project coordination support for the implementation, upgrade, and maintenance of IT computerized systems within a cGMP-regulated environment. This position ensures systems are properly installed, configured, validated, and maintained in compliance with regulatory requirements, internal procedures, and data integrity standards.
Key Responsibilities:
Support IT project implementation activities including planning, coordination, execution, and commissioning of computerized systems.Collaborate with IT and Automation teams on system upgrades, enhancements, and new implementations.Assist in the installation, configuration, and qualification of IT infrastructure, including operating systems and applications.Coordinate project activities to ensure milestones and timelines are achieved.Generate and maintain Standard Operating Procedures (SOPs) related to IT systems.Support change control processes, ensuring systems remain in a validated and compliant state.Assist in the evaluation and implementation of system changes, upgrades, and enhancements.Support validation and qualification activities for IT computerized systems, including documentation and execution.Provide project status updates using project plans and tracking tools.Ensure compliance with cGMP regulations, data integrity requirements, and internal quality standards.Requirements:
Bachelor’s degree in Information Technology, Engineering, Computer Science, or related field.Experience supporting IT projects and computerized systems in regulated environments (cGMP preferred).Knowledge of system implementation, configuration, and validation (CSV lifecycle).Familiarity with change control processes and documentation practices.Strong organizational and project coordination skills.Good communication and teamwork abilities.Experience with operating systems, applications, and IT infrastructure is preferred.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The Automation Technician is responsible for supporting the operation, maintenance, and troubleshooting of automation systems within a cGMP-regulated manufacturing environment. This role ensures reliable system performance by responding to incidents, executing preventive maintenance, and supporting validation and compliance activities.
Key Responsibilities:
Diagnose and resolve issues related to PLCs, SCADA, DCS, and networked manufacturing equipment.Provide onsite overnight support, ensuring rapid response to alarms, system faults, and equipment failures.Execute preventive maintenance (PM) activities for automation systems, ensuring tasks are completed accurately and on schedule.Perform root cause analysis for automation incidents and support CAPA implementation.Support validation activities including testing and documentation as required.Ensure all activities are performed in compliance with cGMP regulations, data integrity standards, and site quality procedures.Maintain proper documentation of system status, incidents, and maintenance activities.Requirements:
Associate’s or Bachelor’s degree in Engineering, Electronics, or related technical field (or equivalent experience).Hands-on experience with automation systems such as PLC, SCADA, or DCS.Basic troubleshooting skills in industrial control systems and manufacturing equipment.Familiarity with cGMP environments and compliance requirements is preferred.Strong problem-solving and communication skills.Ability to work overnight shifts as required.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The Sr Automation Projects Support role provides advanced technical support for automation systems and project-related activities within a cGMP-regulated manufacturing environment. This position is responsible for troubleshooting, maintenance, system improvements, and supporting validation and compliance efforts to ensure reliable and efficient operations.
Key Responsibilities:
Troubleshoot, diagnose, and resolve issues related to PLCs, SCADA, DCS, OSI PI, communication interfaces, and automated manufacturing equipment.Provide onsite support during overnight operations, ensuring rapid response to alarms, system faults, and equipment failures.Perform root cause analysis for automation incidents and support CAPA implementation.Coordinate and/or perform replacement of components and parts as needed.Execute and maintain preventive maintenance (PM) activities for automation systems, ensuring timely and accurate completion.Support automation projects, system upgrades, and continuous improvement initiatives.Assist in validation activities including protocol execution, testing, CSV documentation, and resolution of findings.Maintain clear shift turnover documentation including system status, incidents, actions taken, and pending items.Ensure all activities comply with cGMP regulations, data integrity standards, cybersecurity policies, and safety requirements.Requirements:
Bachelor’s degree in Engineering (Electrical, Computer, Mechanical) or related field, or equivalent experience.Strong hands-on experience with automation systems (PLC, SCADA, DCS).Experience with data historians such as OSI PI is preferred.Knowledge of troubleshooting industrial control systems and manufacturing equipment.Familiarity with Computer System Validation (CSV) and cGMP environments.Experience supporting preventive maintenance and automation projects.Strong analytical, problem-solving, and communication skills.Ability to work overnight shifts as required.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The CSV Consultant (MES Experience) is responsible for supporting project execution, system design, and Computer System Validation (CSV) activities for Manufacturing Execution Systems (MES) within a cGMP-regulated environment. This role ensures that systems are implemented, validated, and maintained in compliance with regulatory requirements and business needs.
Key Responsibilities:
Project Management:
Estimate task duration and resource requirements to support project planning.Prioritize tasks based on business needs, dependencies, and project milestones.Develop and maintain project schedules, tracking timelines, deliverables, and risks.Coordinate activities across internal teams and external partners to ensure timely execution.Analysis & Design:
Gather and analyze business and system requirements through interviews, workshops, and process reviews.Translate business needs into functional and technical requirements.Prepare technical documentation and presentations for stakeholders (business, QA, technical teams, and leadership).Support system design discussions and contribute to solution definition aligned with user and regulatory requirements.Computer System Validation (CSV):
Develop and execute validation deliverables including Risk Assessments, Validation Protocols, Test Scripts, Deviations, and Summary Reports.Perform and review validation activities in compliance with GxP, 21 CFR Part 11, Annex 11, and internal procedures.Collaborate with Quality Assurance to define and align validation strategies.Ensure all validation documentation meets quality standards and is audit-ready.Requirements:
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.Experience in Computer System Validation (CSV) within regulated environments (pharma/biotech preferred).Hands-on experience with Manufacturing Execution Systems (MES).Strong knowledge of regulatory requirements (GxP, 21 CFR Part 11, Annex 11).Experience in requirements gathering, system design, and technical documentation.Strong project coordination and organizational skills.Excellent communication and stakeholder management abilities.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read LessAbout Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
Job Summary:
The CSV & CQV Specialist is responsible for supporting Computer System Validation (CSV), Commissioning, and Qualification (CQV) activities within a cGMP-regulated environment. This role ensures that systems and equipment are validated, compliant, and operate according to regulatory requirements, data integrity standards, and internal quality procedures.
Key Responsibilities:
Participate in project team meetings, providing input on timelines, deliverables, risks, and task status.Execute CSV and CQV activities including system validation, commissioning, and equipment qualification.Develop and maintain validation documentation such as Validation Plans, Risk Assessments, Traceability Matrices, Test Protocols (IQ/OQ/PQ), and Summary Reports.Support development and revision of SOPs, including administrative and operational procedures.Perform data integrity assessments and support remediation activities.Support installation and operational verification of system interfaces and external connectivity.Lead and support change control activities, including requirement gathering, documentation, and implementation.Generate and present change controls to Change Control Review Boards.Support source code review, system inventory management, and configuration documentation.Ensure compliance with cGMP regulations, data integrity standards, and internal quality systems.Perform general automation and system administration tasks as required.Maintain compliance with training and Individual Learning Plan requirements.Requirements:
Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.Experience in Computer System Validation (CSV) and/or Commissioning & Qualification (CQV) in regulated environments.Strong knowledge of validation lifecycle documentation (URS, DS, IQ/OQ/PQ, TMX, etc.).Familiarity with change control processes and quality systems.Knowledge of data integrity principles and regulatory expectations (FDA, cGMP).Strong organizational, documentation, and communication skills.Ability to manage multiple tasks and work in cross-functional teams.Must be authorized to work in the United States without sponsorship.Location:
Puerto Rico Read Less