Engineer II, Integration
Thermo Fisher · Santa Clara, California, USA
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How You Will Make an Impact: The Engineer II, Integration supports the integration, configuration, testing, and commissioning of automation and bioprocessing systems within Product Engineering, ensuring systems are accurately configured and prepared for Factory Acceptance Testing (FAT) and customer delivery. The role contributes to the transition from engineering requirements and system components to complete, tested, documented, and supportable automation solutions ready for customer acceptance and delivery. This role independently executes assigned system-integration and configuration activities, troubleshoots hardware, software, network, and configuration issues, and resolves technical problems within established engineering standards and procedures while collaborating cross-functionally to support system readiness, reduce integration-related risks, and improve execution. Location: Santa Clara, CA . Relocation assistance is NOT provided. • Must be legally authorized to work in the United States without sponsorship. • Must be able to pass a comprehensive background check, which includes a drug screening. What will you do?: Review system architecture, build definitions, technical documentation, and customer requirements to ensure assigned integration activities are executed accurately. Identify integration-related risks, dependencies, or schedule impacts and communicate or escalate issues appropriately to support project commitments. Build, configure, and verify assigned system infrastructure, including servers, virtual machines, network settings, system communications, software configurations, and related integration components in accordance with approved system architecture and established engineering requirements. Configure and verify assigned DeltaV, TruBio, HCI, server, network, and automation-system components, including system communications, controllers, I/O, operator interfaces, alarms/events, historians, user/security functions, and other applicable features in accordance with approved system architecture and project requirements. Configure and verify assigned TruBio control areas and vessel configurations for applicable single-use equipment, including process parameters, instrumentation, alarms, interlocks, engineering units, ranges, and customer-specific options in accordance with approved system requirements. Configure, test, and troubleshoot communications and interfaces between automation systems and single-use equipment, controllers, PLCs, I/O, instrumentation, Modbus devices, and supported third-party equipment. Configure and verify applicable operator graphics, system navigation, user access, historians, alarms/events, and other operator-facing automation functionality. Independently execute assigned system-integration activities for standard and moderately complex customer configurations, escalating highly complex or non-standard technical issues as appropriate. Maintain accurate and controlled system build records and complete required as-built documentation and system backups, including applicable automation configurations, controllers/I/O, licensing information, and supporting technical documentation, in accordance with established procedures. Document technical issues, troubleshooting activities, configuration changes, test results, and resolutions accurately and in accordance with applicable engineering and quality requirements. Verify system configuration, connectivity, functionality, documentation, and overall readiness prior to Factory Acceptance Testing (FAT). Independently troubleshoot routine-to-complex hardware, software, network, communications, and configuration issues; apply structured problem-solving methods to identify root causes, implement corrective actions within established technical standards, verify effective resolution, and escalate highly complex or systemic issues as appropriate. Prepare assigned systems for FAT, customer acceptance, shipment, installation, and subsequent service support by ensuring configuration, documentation, backups, and required technical records are complete and accurate. Support FAT execution from an integration perspective by ensuring system readiness, resolving assigned technical issues, implementing approved configuration changes, and coordinating with Validation, Engineering, and project stakeholders. Partner with Validation, Manufacturing Engineering, Product Engineering, Project Management, Manufacturing, Service, and other stakeholders to resolve integration issues and support project execution. Provide technical input during project discussions and customer-facing activities within assigned areas of responsibility. Support Service activities for installed systems, expansions, modifications, backup/restoration, and troubleshooting of assigned automation, configuration, networking, communications, and control-system issues. Support NPI activities by executing assigned integration, configuration, commissioning, testing, documentation, and system-readiness activities for new equipment, automation platforms, and product enhancements; identify integration gaps and technical risks and communicate lessons learned to the appropriate Engineering stakeholders. Identify and implement improvements to integration procedures, checklists, technical documentation, troubleshooting practices, and standard workflows to improve quality, repeatability, cycle time, and execution efficiency. Participate in or lead assigned PPI/continuous improvement activities within the scope of the role. Configure, document, and verify assigned automation-system features that support applicable GMP, data-integrity, and 21 CFR Part 11 requirements, including user access/security, audit trails, alarms and events, electronic records, system history, and other compliance-related functions as defined by system and customer requirements. Perform and independently execute assigned integration, configuration, testing, and commissioning activities for automation and bioprocessing systems in accordance with approved system architecture, customer requirements, engineering documentation, and project schedules. Support custom and non-standard system configurations under appropriate engineering direction and within established design requirements. Manage multiple assigned integration activities and project priorities while meeting established schedules and quality requirements. Share technical knowledge and provide informal guidance or peer support to colleagues within areas of demonstrated expertise. Perform other duties as assigned. The responsibilities described above are representative of the nature and level of work performed and are not intended to be an exhaustive list of all duties and responsibilities. Education & Experience: Required: Advanced Degree in Engineering, Computer Science, Automation, Controls, or a related technical discipline; OR Bachelor's Degree in Engineering, Computer Science, Automation, Controls, or a related technical discipline with 2 years of experience in supporting automation, control systems, system integration, commissioning, validation, or other technically complex engineered systems; OR Associate Degree in Engineering, Computer Science, Automation, Controls, or a related technical discipline with 4 years of experience in supporting automation, control systems, system integration, commissioning, validation, or other technically complex engineered systems; OR High School Diploma or equivalent with 6 years of experience in supporting automation, control systems, system integration, commissioning, validation, or other technically complex engineered systems. E
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